Non-Hodgkin's B-cell LymphomaPhase 1/2MT-3724NHL001NCT02361346
Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
A Phase 1/2 study testing MT-3724 Phase 1 and MT-3724 Phase 2 in people with Non-Hodgkin's B-cell Lymphoma and Leukemia, Lymphocytic, Chronic, B-Cell, run by Molecular Templates, Inc. at 41 sites in 10 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of MT-3724 in subjects with relapsed or refractory B-Cell NHL or relapsed and refractory CLL (Part 1 only) and relapsed and refractory DLBCL (Part 2 and Part 3). Part 3 evaluates the efficacy of MT-3724. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's B-cell Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Small Lymphocytic Leukemia
- What is being tested?
- MT-3724 Phase 1 and MT-3724 Phase 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 41 sitesin 10 countries
- Study dates
- Feb 2015to 22 Mar 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be informed about the study and fully consent to participation as demonstrated by signing the written ICF before any screening procedure.
- Male and female participants >= 18 years of age at the time of informed consent.
- Participants must have relapsed or refractory Diffuse large B cell lymphoma (DLBCL) according to the Revised European American Lymphoma/World Health Organization classification. Participants must have proof of cluster of differentiation 20 plus (CD20+) DLBCL, based on either:
- a. historical biopsies (obtained with diagnosis of relapsed or refractory disease), or
- b. fresh biopsies
- c. bone marrow biopsy, excisional lymph node biopsy, and core biopsy of any involved organ are all acceptable methods; Fine Needle Aspirate is not acceptable.
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- Participants must have received at least 2 standard of care (SoC) regimens (including anti-CD20 antibody therapy) appropriate for DLBCL treatment.
- a. Participants whose prior therapy includes chimeric antigen receptor T-cell (CAR-T-cell) therapy are eligible.
- b. Participants who underwent stem cell transplant (SCT) > 100 days for autologous SCT or > 180 days for allogeneic SCT before study drug administration.
- c. Participants who have been ineligible for SoC DLBCL treatments may be eligible at the investigator's discretion, upon sponsor approval.
- Participants must have at least 1 bi-dimensional tumor lesion at screening that is measurable by computerized tomography (CT) and/or magnetic resonance imaging (MRI) according to the Lugano criteria. Bi-dimensionally measurable tumor lesion by CT and/or MRI is defined as longest diameter of > 1.5 centimeters (cm) for lymph nodes and > 1.0 cm for extranodal disease.
- Participants must have life expectancy of > 3 months from the start of treatment.
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Participants must have met ALL the following laboratory criteria:
- a. absolute neutrophil count (ANC) >= 1.0 × 10^9 cells per liter with no myeloid growth factors (granulocyte colony-stimulating factor [G-CSF] or granulocyte-macrophage colony-stimulating factor preparations) administered within 2 weeks of Cycle 1 Day 1.
- b. platelet count >= 50 × 10^9 cells per liter with no Thrombopoietin-receptor agonists agents or platelet transfusions given within 2 weeks of Cycle 1 Day 1.
- c. hemoglobin >= 8.0 grams per deciliter (g/dL) with no erythropoietin stimulating agents or peripheral red blood cell (PRBC) transfusions within 2 weeks of Cycle 1 Day 1
- d. creatinine clearance (CLcr) to be >= 50 milliliter per minute (ml/min) either measured or estimated using the Cockcroft-Gault formula.
- e. total bilirubin (or direct bilirubin for patients with Gilbert's disease < 1.5 × upper limit of normal (ULN)
- f. alanine transaminase (ALT) ≤ 3.0 × ULN (or <= 5.0 x ULN if liver involvement).
- g. aspartate aminotransferase (AST) <= 3.0 × ULN (or <= 5.0 x ULN if liver involvement).
- h. international normalized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN (unless on therapeutic anticoagulants).
- i. Activated partial thromboplastin time <= 1.5 x ULN (unless on therapeutic anticoagulants).
- Have adequate serum albumin, as determined by: a. albumin >= 3.0 g/dL.
- QT interval correction for heart rate using Fridericia's formula (QTcF) <= 480 milliseconds determined as the average of 3 QTcF values from the triplicate electrocardiogram (ECG) obtained at screening.
- Women of reproductive potential must have a negative highly sensitive pregnancy test within 72 hours before the start of treatment. Women who are postmenopausal or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) may be considered as not of reproductive potential.
- Participants of reproductive potential must agree either to abstain continuously from heterosexual intercourse or to use a highly effective birth control method from signing the informed consent until the short term follow-up (STFU) visit for females and until 90 days after the last dose of MT-3724 for males.
- Participants must be able to comply with all study-related procedures and medication use.
Who cannot join
- Prior or Current Therapies
- Received any amount of anti-CD20 monoclonal antibodies (mAbs) within the following periods before the start of treatment:
- a. Rituximab (Rituxan®/MabThera® or rituximab biosimilar): within 84 days (12 weeks); if a participant has received rituximab within 37 weeks before the start of treatment, then serum rituximab level must be negative (< 500 nanograms per milliliter [ng/mL]) at screening.
- b. Obinutuzumab (Gazyva®/Gazyvaro®): 184 days c. Ofatumumab (Arzerra®): 88 days d. Any other anti-CD20 agents (eg, investigational agents), the washout period is 5 half-lives. The investigator must contact the medical monitor to discuss the most Compound: MT-3724 appropriate washout for non-approved CD20-targeting agents, where the half-life (t1/2) is not known.
- Received approved or investigational treatment for DLBCL within 4 weeks before the start of treatment. For small molecules (MW < 0.9 kilodaltons [kDa]), the washout is 5 half-lives or at least 2 weeks. Radioimmunoconjugates are excluded within 12 weeks before the start of treatment.
- Received radiation therapy to tumor lesions that would serve as target lesions (measurable disease) within 4 weeks before the start of treatment, unless the lesion exhibited objective progression between radiation therapy and screening according to the Lugano Classification
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- o a. Palliative radiation therapy to non-target lesions may be permitted at the investigator's discretion after consultation with the medical monitor and sponsor.
- Require the use of systemic immune modulators during study treatment:
- a. Systemic immune modulators include, but are not limited to, systemic corticosteroids at doses > 20 milligrams per day (mg/day) of prednisone equivalent, cyclosporine and tacrolimus.
- b. The use of non-steroidal anti-inflammatory drugs (NSAIDS) is permitted.
- Received any live vaccines within 4 weeks before the start of treatment.
- Prior treatment with MT-3724.
- Medical History
- Current evidence of Common Terminology Criteria for Adverse Events (CTCAE) Grade > 1 toxicity (due to prior anticancer therapy) before the start of treatment, except for hair loss and those Grade 2 toxicities listed as permitted in other eligibility criteria.
- Current evidence of significant (CTCAE Grade ≥ 2) infection or wound within 4 weeks before the start of treatment. a. Participants with Grade 2 infection that has stabilized or improved with oral anti-infectives before the start of treatment may be eligible at the sponsor's discretion.
- Known or suspected hypersensitivity to the study drug or excipients contained in the study drug formulation.
- Current evidence of hypersensitivity or other underlying illness requiring systemic corticosteroids at doses > 20 mg/day prednisone equivalent.
- Current evidence of uncontrolled human immunodeficiency syndrome (HIV), hepatitis B virus (HBV) or /hepatitis C virus (HCV) at screening. Serology testing is not required if seronegativity is documented in the medical history, and if there are no clinical signs suggestive of HIV or hepatitis infections, or suspected exposure. The following exceptions apply for participants with positive viral serology:
- a. Participants with HIV and an undetectable viral load and CD4+ T-cell (CD4+) counts >= 350 cells per milliliter may be enrolled, but must be taking appropriate opportunistic infection prophylaxis, if clinically relevant.
- b. Participants with positive HBV serology are eligible if they have an undetectable viral load and the participant will receive antiviral prophylaxis for potential HBV reactivation per institutional guidelines.
- c. Participants with positive HCV serology are eligible if quantitative polymerase chain reaction (PCR) for plasma HCV ribonucleic acid (RNA) is below the lower limit of detection. Concurrent antiviral HCV treatment per institutional guidelines is allowed.
- Current evidence of incomplete recovery from surgery or radiotherapy before start of treatment, or planned surgery or radiotherapy from the start of treatment until the end of treatment (EoT) visit, except minor elective surgery deemed acceptable by the investigator or palliative radiation therapy to non-target lesions.
- History of cardiovascular, renal, hepatic or any other disease within 3 months before the start of treatment that in the investigator's opinion, may increase the risks associated with study participation or require treatments that may interfere with the conduct of the study or the interpretation of study results.
- History or current evidence of neoplastic disease that is histologically distinct from NHL, except cervical carcinoma in situ, superficial noninvasive bladder tumors, curatively treated Stage I-II non-melanoma skin cancer. Participants with prior, curatively treated cancer > 2 years ago before the start of treatment can be enrolled.
- Current evidence of new or growing brain or spinal metastases during screening. Participants with known brain or spinal metastases may be eligible if they:
- a. Had radiotherapy or another appropriate therapy for the brain or spinal metastases; concurrent prophylactic treatment is allowed
- b. Neurologic symptoms must be stable and no worse than Grade 2
- c. Have evidence of stable brain or spinal disease on CT or MRI scan obtained within 4 weeks before signing the informed consent and compared with prior imaging results
- d. Do not require steroid therapy (or, if applicable, have been stable on dose of no more than prednisone 20 mg/day or equivalent by C1D1)
- Women who are pregnant or breastfeeding.
- History of non-adherence to the schedule of procedures or medication use. 18. Current evidence of Graft vs Host Disease
- History or current evidence of significant cardiovascular disease including, but not limited to, the following conditions:
- a. Unstable angina (symptoms of angina at rest) or new-onset angina within 3 months before the start of treatment.
- b. Arterial thrombosis or pulmonary embolism within 3 months before the start of treatment.
- c. Myocardial infarction or stroke within 3 months before the start of treatment.
- d. Pericarditis (any CTCAE grade), pericardial effusion (CTCAE Grade >= 2), non-malignant pleural effusion (CTCAE Grade ≥ 2) or malignant pleural effusion (CTCAE Grade >= 3) within 3 months before the start of treatment with MT-3724.
- e. Congestive heart failure (New York Heart Association [NYHA] Class III or IV) at screening or left ventricular ejection fraction (LVEF) <= 45 percent (%), assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 1 month before starting study treatment (inclusion of participants with LVEF between 40% to 45% should be discussed with the medical monitor and approved by the sponsor). (ECHO or MUGA performed within 6 months before screening and at least 28 days after the last cancer therapy is acceptable provided the participant has not received any potentially cardiotoxic agents since then).
- f. Cardiac arrhythmia requiring anti-arrhythmic therapy at screening. Participants receiving digoxin, calcium channel blockers, or beta-adrenergic blockers are eligible at the investigator's discretion after consultation with medical monitor and sponsor if the dose has been stable for >= 2 weeks before the start of treatment with MT-3724. Participants with sinus arrhythmia and infrequent premature ventricular contractions are eligible at the investigator's discretion.
Trial locations and contacts
41 sites in 10 countries.
41 sites in 10 countries
United States17 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Illinois, Cancer Center
Chicago, Illinois, 60612
Columbus Regional Research Institute
Columbus, Georgia, 31904
MD Anderson Cancer Center
Houston, Texas, 77030
21st Century Oncology - Jacksonville
Jacksonville, Florida, 32204
Norton Healthcare, Inc
Louisville, Kentucky
New York University Langone Medical Center
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Orlando Health, Inc.
Orlando, Florida, 32806
Orlando Health, Inc.
Orlando, Florida
BRCR Medical Center
Plantation, Florida, 33322
UT Health San Antonio Cancer
San Antonio, Texas, 78229
Healthcare Research Network III, LLC
Tinley Park, Illinois
University of Arizona
Tucson, Arizona, 85724
Carle Foundation Hospital
Urbana, Illinois
ASCLEPES Research Centers
Weeki Wachee, Florida, 34607
Innovative Clinical Research Institute, LLC
Whittier, California, 90602
Poland6 sites
Maria Sklodowska-Curie National Institute of Oncology - National Research Institute
Gliwice
University Hospital in Krakow, Teaching Unit of the Hematology Department
Krakow
Frederic Chopin Provincial Teaching Hospital, Teaching Department of Hematology
Rzeszów, 35-055
Our Doctor Clinical Trials Center
Torun
Institute of Hematology and Transfusion Medicine, Department of Hematology
Warsaw
Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation
Wroclaw, 50-367
Canada4 sites
Cross Cancer Institute
Edmonton, Alberta
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 2V7
Montreal Oncology Research
Québec, H1M 1B1
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Spain4 sites
Catalan Institute of Oncology (ICO) - Hospital Duran i Reynals, Department of Clinical Hematology
Barcelona
University Hospital Vall d'Hebron (HUVH), Department of Hematology
Barcelona
Hospital Universitario QuironSalud Madrid
Madrid, 28223
University Hospital Virgen del Rocio (HUVR), Department of Hematology
Seville
Israel3 sites
Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute
Petah Tikva, 49100
Chaim Sheba Medical Center, Department of Hematology
Ramat Gan
The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation
Tel Aviv
Belarus2 sites
Grodno University Hospital
Grodno
Minsk City Clinical Oncology Center
Minsk, 220013
Serbia2 sites
Clinical Center Kragujevac, Clinic of Hematology
Kragujevac
Clinical Center of Vojvodina, Clinic of Hematology
Novi Sad
Ukraine1 site
Medical Center of Limited Liability Company "Medical Centre Named by Academician Yurii Spizhenko
Kyiv, 08112
About this study
Official title: Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
The purpose of this study is to evaluate the safety and tolerability of MT-3724 in subjects with relapsed or refractory B-Cell NHL or relapsed and refractory CLL (Part 1 only) and relapsed and refractory DLBCL (Part 2 and Part 3). Part 3 evaluates the efficacy of MT-3724.
Read the detailed description
This is a three-part Phase 2 study
Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 [Completed]
Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 in the MTD Expansion Cohort.
Part 3: (Phase 2 MTD Expansion Cohort) Determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL based on the overall response rate (ORR) by the revised Lugano Classification for Lymphoma adjusted according to LYRIC.
It is anticipated that up to 100 patients will be enrolled in Part 3. Treatment will continue for up to six 21 days cycles. If the subject exhibits SD, CR or PR after the end of Cycle 6 and the investigator determines that the benefit-risk ratio is favorable, then the treatment with MT-3724 may be continued after discussion with the sponsor.
- Conditions
- Non-Hodgkin's B-cell Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Small Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Blood Cancer, Hematological Malignancy
- Being tested
- MT-3724 Phase 1, MT-3724 Phase 2
- Keywords
- CD20, immunotoxin, NHL, non-Hodgkin's lymphoma, lymphoma, cancer, antibodies, immunotherapy, safety, pharmacokinetics, maximum tolerated dose, MT-3724, relapsed, refractory, leukemia, CLL, SLL, DLBCL, efficacy
- Medical subject headings
- Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, Hematologic Neoplasms, Lymphoma, Non-Hodgkin, Lymphoma, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-3724 Phase 1Drug
Intravenous dosing Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 2 hours on each dosing day over 28 day initial cycle and then 21 week repeat cycles for up to 5 total cycles.
MT-3724 Phase 2Drug
Intravenous dosing on Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 1 hour on each dosing day over 21 day cycle up to 6 cycles and then can be continued for 6 additional cycles.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) | Experimental | Part 1: MT-3724 5 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined Receives: Drug: MT-3724 Phase 1 |
| Part 1: Cohort 2- 10 mcg/kg/Dose | Experimental | Part 1: MT-3724 10 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part) until recommended phase 2 dose of MT-3724 is determined Receives: Drug: MT-3724 Phase 1 |
| Part 1: Cohort 3- 20 mcg/kg/Dose | Experimental | Part 1: MT-3724 20 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined Receives: Drug: MT-3724 Phase 1 |
| Part 1: Cohort 4- 50 mcg/kg/Dose | Experimental | Part 1: MT-3724 50 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined Receives: Drug: MT-3724 Phase 1 |
| Part 1: Cohort 5- 100 mcg/kg/Dose | Experimental | Part 1: MT-3724 100 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined Receives: Drug: MT-3724 Phase 1 |
| Part 1: Cohort 6- 75 mcg/kg/Dose | Experimental | Part 1b: MT-3724 75 mcg/kg/dose IV for 6 doses over 12 days of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724 (subject will continue with dose that was tolerated in the Part 1 portion of the study) Receives: Drug: MT-3724 Phase 1 |
| Part 2: Cohort 7- MTD Expansion Cohort | Experimental | Part 2: MT-3724 IV for 6 doses administered within 14 days of 21-Day cycle up to 6 Cycles. If the Subject exhibits stable disease or PR after end of Cycle 6 and investigator determines ratio is favorable, treatment with MT- 3724 may be continued for up to additional 6 cycles. Receives: Drug: MT-3724 Phase 1; Drug: MT-3724 Phase 2 |
| Part 3: All MT-3724 Treated Participants | Experimental | Part 3: MT-3724 IV 50 µg/kg/dose administered on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle. Treatment will continue until death, disease progression, unacceptable toxicity, withdrawal of consent, or another reason for withdrawal, or until study discontinuation Receives: Drug: MT-3724 Phase 2 |
| Part 4: All MT-3724 Treated Participants | Experimental | Part 4: In this arm, subjects were planned to receive all doses of MT-3724 as IV infusion as confirmed in Part 3. Receives: Drug: MT-3724 Phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724
The MTD is defined to be the dose cohort below which participants experience dose-limiting toxicities during cycle 1. Dose-limiting toxicities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Measured: Days 1, 3, 5, 8, 10 and 12
Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274
Blood samples were collected at indicated timepoints for the determination of Cmax of MT-3274.
Measured: Part 1 and 2 : Days 1, 3 and 12
Part 1 and 2: Time to Achieve Cmax (Tmax) of MT-3724
Blood samples were collected at indicated timepoints for the determination of tmax.
Measured: Part 1 and 2: Days 1, 3 and 12
Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724
Blood samples were collected at indicated timepoints for the determination of AUC (0-4), AUC (0-infinity) and AUClast.
Measured: Part 1 and 2: Days 1, 3 and 12
Part 1 and 2: Half Life (t1/2) of MT-3724
Blood samples were collected at indicated timepoints for the analysis of t1/2 of MT-3724.
Measured: Part 1 and 2: Days 1, 3 and 12
Part 1 and 2: Volume of Distribution (Vz) of MT-3724
Blood samples were collected at indicated timepoints for the analysis of Vz of MT-3724.
Measured: Part 1 and 2: Days 1, 3 and 12
Part 1 and 2: Clearance (CL) of MT-3724
Blood samples were collected at indicated timepoints for the analysis of CL of MT-3724.
Measured: Part 1 and 2: Days 1, 3 and 12
Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes
CD19+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus
Measured: Part 1 and 2: Cycle 1: Days 8 and 23; Cycle 3: Day1; Cycle 5: Day 1 and Day 120 (end of study)
Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed
Blood samples were collected to analyze the presence of ADA that bind MT-3724. Number of participants with positive ADA confirmed has been presented.
Measured: Part 1 and 2: Cycle 1, Day 23; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 5, Day 1 and Day 120 (end of study)
Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Measured: Up to Day 45
Part 3: Number of Participants With Clinically Significant Laboratory Parameters
Blood samples were collected at indicated timepoints for the analysis of laboratory parameters.
Measured: Up to Day 45
Part 3: Number of Participants With Clinically Significant Electrocardiogram (ECG) Values
Standard resting 12-lead ECG assessments was performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.
Measured: Up to Day 26
Part 3: Number Participants With Clinically Significant Vital Signs
Vital signs including systolic and diastolic blood pressure, respiratory rate, heart rate and body temperature were assessed at indicated time points.
Measured: Up to Day 45
Part 3: Number of Participants With Clinically Significant Physical Findings
Physical examination was performed by a physician or a qualified delegate at the investigating site.
Measured: Up to Day 26
Part 4: Overall Response Rate (ORR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by independent, blinded central review.
Measured: Up to Day 45
Secondary outcomes (36)
Part 1 and 2: Number of Participants Reporting Worst Case Serious Treatment Emergent Adverse Events (TEAEs) and Non-serious TEAEs
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Measured: Up to Day 45
Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL by the Lugano Classification for Lymphoma
Overall response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) as determined by independent, blinded central review board.
Measured: Up to Day 45
Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.
Measured: Up to Day 45
Part 3: Duration of Tumor Response (DOR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
DOR defined as time from initial documentation of tumor response (CR or PR) to disease progression.
Measured: Up to Day 45
Part 3: Disease Control Rate (DCR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
DCR defined as percentage of participants who have achieved CR, PR and stable disease.
Measured: Up to Day 45
Part 3: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.
Measured: Up to Day 45
Part 3: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of tmax of MT-3724 monotherapy.
Measured: Up to Day 45
Part 3: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.
Measured: Up to Day 45
Part 3: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.
Measured: Up to Day 45
Part 3: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.
Measured: Up to Day 45
Part 3: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy
Measured: Up to Day 45
Part 3: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.
Measured: Up to Day 45
Part 3: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.
Measured: Up to Day 45
Part 3: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.
Measured: Up to Day 45
Part 3: Number of Participants With ADA When Treated With MT-3724
Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.
Measured: Up to Day 45
Part 4: DOR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Duration of response was defined as the time from the first occurrence of either complete or partial response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were planned to be censored at time of last disease assessment. Only responders (CR or PR) were planned to be included for this analysis.
Measured: Up to Day 45
Part 4: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Measured: Up to Day 45
Part 4: Number of Participants With SAEs
A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement or is associated with liver injury and impaired liver function.
Measured: Up to Day 45
Part 4: Number of Participants With Clinically Significant Laboratory Parameters
Blood samples were planned to be collected for the analysis of laboratory parameters.
Measured: Up to Day 45
Part 4: Number Participants With Clinically Significant Vital Signs
Vital signs parameters including systolic and diastolic blood pressure, heart rate, respiration rate, body temperature and body weight were planned to be analyzed.
Measured: Up to Day 45
Part 4: Number of Participants With Clinically Significant ECG Values
Standard resting 12-lead ECG assessments was planned to be performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.
Measured: Up to Day 26
Part 4: Number of Participants With Adverse Events Suggestive of Cardiotoxicity
Number of participants with any adverse events leading to cardiotoxicity when treated with MT-3724 was planned to be analyzed.
Measured: Up to Day 26
Part 4: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall response rate was defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.
Measured: Up to Day 45
Part 4: DCR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
DCR was defined as percentage of participants who has achieved CR, PR and stable disease.
Measured: Up to Day 45
Part 4: Progression-free Survival (PFS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Progression-free survival was defined as the time from study enrollment to the earliest date of disease progression or death from any cause.
Measured: Up to Day 45
Part 4: Overall Survival (OS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall survival was defined as the time from study enrollment to death from any cause.
Measured: Up to Day 45
Part 4: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.
Measured: Up to Day 45
Part 4: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Tmax of MT-3724 monotherapy.
Measured: Up to Day 45
Part 4: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.
Measured: Up to Day 45
Part 4: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.
Measured: Up to Day 45
Part 4: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.
Measured: Up to Day 45
Part 4: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy.
Measured: Up to Day 45
Part 4: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.
Measured: Up to Day 45
Part 4: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.
Measured: Up to Day 45
Part 4: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.
Measured: Up to Day 45
Part 4: Number of Participants With ADA When Treated With MT-3724
Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.
Measured: Up to Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion22 Mar 2021
- Study completion22 Mar 2021
Why it stopped: Sponsor decision following clinical hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molecular Templates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361346
- Sponsor's protocol ID
- MT-3724_NHL_001
- Acronym
- MT-3724NHL001
- Status last verified
- Jul 2022
- First submitted
- 3 Feb 2015
- Last updated
- 18 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
- ClinicalTrials.gov ID
- NCT02361346
- Acronym / sponsor ID
- MT-3724NHL001 / MT-3724_NHL_001
- Conditions
- Non-Hodgkin's B-cell Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Small Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Blood Cancer, Hematological Malignancy
- Keywords
- CD20, immunotoxin, NHL, non-Hodgkin's lymphoma, lymphoma, cancer, antibodies, immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision following clinical hold
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Molecular Templates, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Posted 18 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of MT-3724 in subjects with relapsed or refractory B-Cell NHL or relapsed and refractory CLL (Part 1 only) and relapsed and refractory DLBCL (Part 2 and Part 3). Part 3 evaluates the efficacy of MT-3724.
Detailed description
This is a three-part Phase 2 study
Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 [Completed]
Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 in the MTD Expansion Cohort.
Part 3: (Phase 2 MTD Expansion Cohort) Determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL based on the overall response rate (ORR) by the revised Lugano Classification for Lymphoma adjusted according to LYRIC.
It is anticipated that up to 100 patients will be enrolled in Part 3. Treatment will continue for up to six 21 days cycles. If the subject exhibits SD, CR or PR after the end of Cycle 6 and the investigator determines that the benefit-risk ratio is favorable, then the treatment with MT-3724 may be continued after discussion with the sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) | Experimental | Drug: MT-3724 Phase 1Part 1: MT-3724 5 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined |
| Part 1: Cohort 2- 10 mcg/kg/Dose | Experimental | Drug: MT-3724 Phase 1Part 1: MT-3724 10 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part) until recommended phase 2 dose of MT-3724 is determined |
| Part 1: Cohort 3- 20 mcg/kg/Dose | Experimental | Drug: MT-3724 Phase 1Part 1: MT-3724 20 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined |
| Part 1: Cohort 4- 50 mcg/kg/Dose | Experimental | Drug: MT-3724 Phase 1Part 1: MT-3724 50 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined |
| Part 1: Cohort 5- 100 mcg/kg/Dose | Experimental | Drug: MT-3724 Phase 1Part 1: MT-3724 100 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined |
| Part 1: Cohort 6- 75 mcg/kg/Dose | Experimental | Drug: MT-3724 Phase 1Part 1b: MT-3724 75 mcg/kg/dose IV for 6 doses over 12 days of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724 (subject will continue with dose that was tolerated in the Part 1 portion of the study) |
| Part 2: Cohort 7- MTD Expansion Cohort | Experimental | Drug: MT-3724 Phase 1, Drug: MT-3724 Phase 2Part 2: MT-3724 IV for 6 doses administered within 14 days of 21-Day cycle up to 6 Cycles. If the Subject exhibits stable disease or PR after end of Cycle 6 and investigator determines ratio is favorable, treatment with MT- 3724 may be continued for up to additional 6 cycles. |
| Part 3: All MT-3724 Treated Participants | Experimental | Drug: MT-3724 Phase 2Part 3: MT-3724 IV 50 µg/kg/dose administered on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle. Treatment will continue until death, disease progression, unacceptable toxicity, withdrawal of consent, or another reason for withdrawal, or until study discontinuation |
| Part 4: All MT-3724 Treated Participants | Experimental | Drug: MT-3724 Phase 2Part 4: In this arm, subjects were planned to receive all doses of MT-3724 as IV infusion as confirmed in Part 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Participants must be informed about the study and fully consent to participation as demonstrated by signing the written ICF before any screening procedure.
- Male and female participants >= 18 years of age at the time of informed consent.
- Participants must have relapsed or refractory Diffuse large B cell lymphoma (DLBCL) according to the Revised European American Lymphoma/World Health Organization classification. Participants must have proof of cluster of differentiation 20 plus (CD20+) DLBCL, based on either:
- Participants must have received at least 2 standard of care (SoC) regimens (including anti-CD20 antibody therapy) appropriate for DLBCL treatment.
- Participants must have at least 1 bi-dimensional tumor lesion at screening that is measurable by computerized tomography (CT) and/or magnetic resonance imaging (MRI) according to the Lugano criteria. Bi-dimensionally measurable tumor lesion by CT and/or MRI is defined as longest diameter of > 1.5 centimeters (cm) for lymph nodes and > 1.0 cm for extranodal disease.
Key exclusion criteria (38 listed)
- Prior or Current Therapies
- Received any amount of anti-CD20 monoclonal antibodies (mAbs) within the following periods before the start of treatment:
- Received approved or investigational treatment for DLBCL within 4 weeks before the start of treatment. For small molecules (MW < 0.9 kilodaltons [kDa]), the washout is 5 half-lives or at least 2 weeks. Radioimmunoconjugates are excluded within 12 weeks before the start of treatment.
- Received radiation therapy to tumor lesions that would serve as target lesions (measurable disease) within 4 weeks before the start of treatment, unless the lesion exhibited objective progression between radiation therapy and screening according to the Lugano Classification
- o a. Palliative radiation therapy to non-target lesions may be permitted at the investigator's discretion after consultation with the medical monitor and sponsor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-3724 Phase 1Intravenous dosing Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 2 hours on each dosing day over 28 day initial cycle and then 21 week repeat cycles for up to 5 total cycles. | Drug | Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose), Part 1: Cohort 2- 10 mcg/kg/Dose, Part 1: Cohort 3- 20 mcg/kg/Dose, Part 1: Cohort 4- 50 mcg/kg/Dose, Part 1: Cohort 5- 100 mcg/kg/Dose, Part 1: Cohort 6- 75 mcg/kg/Dose, Part 2: Cohort 7- MTD Expansion Cohort |
| MT-3724 Phase 2Intravenous dosing on Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 1 hour on each dosing day over 21 day cycle up to 6 cycles and then can be continued for 6 additional cycles. | Drug | Part 2: Cohort 7- MTD Expansion Cohort, Part 3: All MT-3724 Treated Participants, Part 4: All MT-3724 Treated Participants |
Primary outcome
Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724
Time frame: Days 1, 3, 5, 8, 10 and 12
The MTD is defined to be the dose cohort below which participants experience dose-limiting toxicities during cycle 1. Dose-limiting toxicities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274
Time frame: Part 1 and 2 : Days 1, 3 and 12
Blood samples were collected at indicated timepoints for the determination of Cmax of MT-3274.
Part 1 and 2: Time to Achieve Cmax (Tmax) of MT-3724
Time frame: Part 1 and 2: Days 1, 3 and 12
Blood samples were collected at indicated timepoints for the determination of tmax.
Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724
Time frame: Part 1 and 2: Days 1, 3 and 12
Blood samples were collected at indicated timepoints for the determination of AUC (0-4), AUC (0-infinity) and AUClast.
Part 1 and 2: Half Life (t1/2) of MT-3724
Time frame: Part 1 and 2: Days 1, 3 and 12
Blood samples were collected at indicated timepoints for the analysis of t1/2 of MT-3724.
Part 1 and 2: Volume of Distribution (Vz) of MT-3724
Time frame: Part 1 and 2: Days 1, 3 and 12
Blood samples were collected at indicated timepoints for the analysis of Vz of MT-3724.
Part 1 and 2: Clearance (CL) of MT-3724
Time frame: Part 1 and 2: Days 1, 3 and 12
Blood samples were collected at indicated timepoints for the analysis of CL of MT-3724.
Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes
Time frame: Part 1 and 2: Cycle 1: Days 8 and 23; Cycle 3: Day1; Cycle 5: Day 1 and Day 120 (end of study)
CD19+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus
Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed
Time frame: Part 1 and 2: Cycle 1, Day 23; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 5, Day 1 and Day 120 (end of study)
Blood samples were collected to analyze the presence of ADA that bind MT-3724. Number of participants with positive ADA confirmed has been presented.
Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs
Time frame: Up to Day 45
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Part 3: Number of Participants With Clinically Significant Laboratory Parameters
Time frame: Up to Day 45
Blood samples were collected at indicated timepoints for the analysis of laboratory parameters.
Part 3: Number of Participants With Clinically Significant Electrocardiogram (ECG) Values
Time frame: Up to Day 26
Standard resting 12-lead ECG assessments was performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.
Part 3: Number Participants With Clinically Significant Vital Signs
Time frame: Up to Day 45
Vital signs including systolic and diastolic blood pressure, respiratory rate, heart rate and body temperature were assessed at indicated time points.
Part 3: Number of Participants With Clinically Significant Physical Findings
Time frame: Up to Day 26
Physical examination was performed by a physician or a qualified delegate at the investigating site.
Part 4: Overall Response Rate (ORR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by independent, blinded central review.
36 secondary outcomes
Part 1 and 2: Number of Participants Reporting Worst Case Serious Treatment Emergent Adverse Events (TEAEs) and Non-serious TEAEs
Time frame: Up to Day 45
Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL by the Lugano Classification for Lymphoma
Time frame: Up to Day 45
Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 3: Duration of Tumor Response (DOR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 3: Disease Control Rate (DCR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 3: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 3: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 3: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 3: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 3: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 3: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 3: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL
Time frame: Up to Day 45
Part 3: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL
Time frame: Up to Day 45
Part 3: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL
Time frame: Up to Day 45
Part 3: Number of Participants With ADA When Treated With MT-3724
Time frame: Up to Day 45
Part 4: DOR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 4: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs
Time frame: Up to Day 45
Part 4: Number of Participants With SAEs
Time frame: Up to Day 45
Part 4: Number of Participants With Clinically Significant Laboratory Parameters
Time frame: Up to Day 45
Part 4: Number Participants With Clinically Significant Vital Signs
Time frame: Up to Day 45
Part 4: Number of Participants With Clinically Significant ECG Values
Time frame: Up to Day 26
Part 4: Number of Participants With Adverse Events Suggestive of Cardiotoxicity
Time frame: Up to Day 26
Part 4: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 4: DCR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 4: Progression-free Survival (PFS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 4: Overall Survival (OS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 4: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 4: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 4: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 4: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 4: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 4: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Time frame: Up to Day 45
Part 4: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL
Time frame: Up to Day 45
Part 4: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL
Time frame: Up to Day 45
Part 4: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL
Time frame: Up to Day 45
Part 4: Number of Participants With ADA When Treated With MT-3724
Time frame: Up to Day 45
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MT-3724 Phase 1 and MT-3724 Phase 2 in people with Non-Hodgkin's B-cell Lymphoma and Leukemia, Lymphocytic, Chronic, B-Cell, run by Molecular Templates, Inc. at 41 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Poland, Canada, Spain, Israel and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 (time frame: Days 1, 3, 5, 8, 10 and 12). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.