B-cell Non-Hodgkins LymphomaPhase 1NCT02924402
Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies
A Phase 1 study testing XmAb13676 in people with B-cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia, run by Xencor, Inc. at 23 sites in 4 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia
- What is being tested?
- XmAb13676
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 23 sitesin 4 countries
- Study dates
- Oct 2016to Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Able to provide written informed consent
- Diagnosis of either Non-CLL B cell malignancy
- Ineligible for or have exhausted standard therapeutic options and have relapsed or refractory disease
- ECOG performance status 0-2
- Fertile patients must agree to use highly effective contraception during and for 5 months (male patients) and 8 months (female patients) after last dose of XmAb13676
- Able and willing to complete the entire study
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- Additional Patient Inclusion Criteria for the DLBCL Cohort (Expansion Phase)
- Histologically confirmed diagnosis (specified by 2016 World Health Organization) of DLBCL or transformed low-grade lymphoma with measurable disease
- Patient must be refractory or have relapsed after 2 or more standard therapeutic options, at least one of which must have included anti-CD20 antibody therapy.
- Not a candidate for or refusing treatment with hematopoietic stem cell transplantation
- Additional Patient Inclusion Criteria for the Follicular Lymphoma Cohort (Expansion Phase)
- Diagnosis of follicular lymphoma Grades 1-3a
- Patient must be ineligible for or have exhausted standard therapeutic options and have had 2 or more prior systemic regimens.
Who cannot join
- Cytotoxic chemotherapy, radiotherapy, or immunotherapy including other anti-CD20 antibodies within 4 weeks, or small molecule or investigational agents within 5 elimination half-lives of the first dose of XmAb13676
- Prior solid organ transplantation
- Failure to recover from Grade 3 or 4 toxicity from previous treatment
- Multiple myeloma/plasma cell leukemia or B cell acute lymphoblastic leukemia
- Known intolerance to CD20 monoclonal antibody therapy
- History of primary central nervous system lymphoma or neoplastic central nervous system disease
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- Platelet count < 50 x 10^9/L
- Absolute neutrophil count < 1.0 x 10^9/L
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) at screening > 3x upper limit of normal (ULN)
- Bilirubin > 1.5 mg/dL unless prior diagnosis and documentation of ongoing hemolysis or Gilbert's syndrome has been made)
- Estimated creatinine clearance < 40 mL/min
- Active/uncontrolled autoimmune disease
- Clinically significant cardiac/cardiovascular disease, or pulmonary compromise
- Seizure disorder
- History of stroke with the past 6 mos prior to study entry
- History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completion
- Evidence of any serious bacterial, viral, parasitic or systemic fungal infections within the 30 days prior to study entry
- Positive test for human immunodeficiency virus (HIV) or hepatitis C (HCV) antibodies (unless HCV viral load test by PCR is negative)
- Positive test for HbsAg, or positive test for HBcAb (unless serology is positive due to recent intravenous immunoglobulin therapy). HBcAb positivity will be allowed if HBsAb is present or HBV-DNA is negative and patient is receiving Hep B reactivation prophylaxis.
- Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, and 8 months after the last dose of study drug
- Positive urine pregnancy test (ie, urine human chorionic gonadotropin) at screening
- Live viral vaccine within 2 weeks of the first dose of XmAb13676
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
France11 sites
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076
Hopital Henri Mondor
Créteil, 94010
Institut Paoli Calmette Dpt of Oncology/Hematology
Marseille, 13273
Chu Montpellier, Hematologie Clinique St. Eloi
Montpellier, 34295
CHU de Nantes
Nantes, 44000
Centre Antoine Lacassagne
Nice, 06189
CHU Haut-Leveque, Service d'Hematologie Clinique et Therapie Cellulaire
Pessac, 33604
Centre Hospitalier Lyon-Sud, Service d'Hematologie
Pierre-Bénite, 69495
Centre Henri Becquerel
Rouen, 76038
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31100
CLCC Institut Gustave Roussy
Villejuif, 94805
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109
Northside Hospital
Atlanta, Georgia, 30342
UVA Health System, Division of Hematology & Oncology
Charlottesville, Virginia, 22908
The University of Chicago Medicine
Chicago, Illinois, 60637
The Ohio State University Wexner Medical Center and James Cancer Hospital
Columbus, Ohio, 43210
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Moores UC San Diego Cancer Center
La Jolla, California, 92093
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Swedish Cancer Institute
Seattle, Washington, 98104
United Kingdom1 site
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-Expressing Hematologic Malignancies
The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD).
- Being tested
- XmAb13676
- Keywords
- NHL, B-cell Prolymphocytic Leukemia, Transformed Lymphoma, Burkitt's Lymphoma, Mantle Cell Lymphoma, Hairy Cell Leukemia, Splenic Marginal Zone Lymphoma, Waldenstrom's Macroglobulinemia, Variant Hairy Cell Leukemia, Splenic B-cell Lymphoma/Leukemia, Lymphoplasmacytic Lymphoma, Extranodal Marginal Zone Lymphoma (MALT), MALT Lymphoma, Nodal Marginal Zone Lymphoma, Follicular Lymphoma, In Situ Follicular Neoplasia, Duodenal-type Follicular Lymphoma, Large B-cell Lymphoma with IRF4 rearrangement, Primary Cutaneous Follicle Center Lymphoma, Diffuse Large B-cell Lymphoma
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Prolymphocytic, B-Cell, Burkitt Lymphoma, Lymphoma, Mantle-Cell, Leukemia, Hairy Cell, Waldenstrom Macroglobulinemia, Leukemia, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb13676Biological
Biological
| Study group | Role | What they receive |
|---|---|---|
| Non-CLL B Cell Malignancies (Group NHL) Part A | Experimental | XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion Receives: Biological: XmAb13676 |
| CLL/SLL (Group CLL) Part A | Experimental | XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion Receives: Biological: XmAb13676 |
| Non-CLL B Cell Malignancies (Group NHL) Part B | Experimental | XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion Receives: Biological: XmAb13676 |
| CLL/SLL (Group CLL) Part B | Experimental | XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion Receives: Biological: XmAb13676 |
| Non-CLL B Cell Malignancies (Group NHL) Part C / Expansion | Experimental | XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion Receives: Biological: XmAb13676 |
| Non-CLL B Cell Malignancies (Group NHL) Part D / Expansion | Experimental | XmAb13676 administered SC up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion Receives: Biological: XmAb13676 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Measured: Baseline Day 1 through Day 56
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing
Measured: Baseline Day 1 through Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2024
- Study completionApr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkins 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will enroll two parallel disease groups in escalation: patients with non-CLL B cell malignancies and patients with CLL/SLL/Richter's Transformation. In expansion it will enroll DLBCL and FL
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Chet Bohac, PharmD, MD, MSc, Study director, Executive Medical Director, Clinical Development, Xencor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924402
- Sponsor's protocol ID
- XmAb13676-01
- Status last verified
- Nov 2024
- First submitted
- 14 Sep 2016
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-Expressing Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02924402
- Acronym / sponsor ID
- XmAb13676-01
- Keywords
- NHL, B-cell Prolymphocytic Leukemia, Transformed Lymphoma, Burkitt's Lymphoma, Mantle Cell Lymphoma, Hairy Cell Leukemia, Splenic Marginal Zone Lymphoma, Waldenstrom's Macroglobulinemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2024 (actual)
- Study completion
- Apr 2024 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
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 determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This study will enroll two parallel disease groups in escalation: patients with non-CLL B cell malignancies and patients with CLL/SLL/Richter's Transformation. In expansion it will enroll DLBCL and FL
| Arm | Type | Receives |
|---|---|---|
| Non-CLL B Cell Malignancies (Group NHL) Part A | Experimental | Biological: XmAb13676XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
| CLL/SLL (Group CLL) Part A | Experimental | Biological: XmAb13676XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
| Non-CLL B Cell Malignancies (Group NHL) Part B | Experimental | Biological: XmAb13676XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
| CLL/SLL (Group CLL) Part B | Experimental | Biological: XmAb13676XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
| Non-CLL B Cell Malignancies (Group NHL) Part C / Expansion | Experimental | Biological: XmAb13676XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
| Non-CLL B Cell Malignancies (Group NHL) Part D / Expansion | Experimental | Biological: XmAb13676XmAb13676 administered SC up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Able to provide written informed consent
- Diagnosis of either Non-CLL B cell malignancy
- Ineligible for or have exhausted standard therapeutic options and have relapsed or refractory disease
- ECOG performance status 0-2
- Fertile patients must agree to use highly effective contraception during and for 5 months (male patients) and 8 months (female patients) after last dose of XmAb13676
Key exclusion criteria (22 listed)
- Cytotoxic chemotherapy, radiotherapy, or immunotherapy including other anti-CD20 antibodies within 4 weeks, or small molecule or investigational agents within 5 elimination half-lives of the first dose of XmAb13676
- Prior solid organ transplantation
- Failure to recover from Grade 3 or 4 toxicity from previous treatment
- Multiple myeloma/plasma cell leukemia or B cell acute lymphoblastic leukemia
- Known intolerance to CD20 monoclonal antibody therapy
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 |
|---|---|---|
| XmAb13676Biological | Biological | CLL/SLL (Group CLL) Part A, CLL/SLL (Group CLL) Part B, Non-CLL B Cell Malignancies (Group NHL) Part A, Non-CLL B Cell Malignancies (Group NHL) Part B, Non-CLL B Cell Malignancies (Group NHL) Part C / Expansion, Non-CLL B Cell Malignancies (Group NHL) Part D / Expansion |
Primary outcome
Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: Baseline Day 1 through Day 56
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing
Time frame: Baseline Day 1 through Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- 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.
Chet Bohac, PharmD, MD, MSc study director
Executive Medical Director, Clinical Development, Xencor, Inc.
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XmAb13676 in people with B-cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia, run by Xencor, Inc. at 23 sites in 4 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 13 inclusion and 22 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: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France, United States, South Korea, United Kingdom. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03 (time frame: Baseline Day 1 through Day 56). The study lists 2 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 13 Nov 2024.