Mantle Cell LymphomaPhase 1NCT04072458
A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies
A Phase 1 study testing L-Bcl-2 antisense oligonucleotide in people with Mantle Cell Lymphoma and Peripheral T-cell Lymphoma (PTCL), run by Bio-Path Holdings, Inc. at 5 sites in United States.
Trial summary
This study evaluates the safety, pharmacokinetics, and efficacy of BP1002 (L-Bcl-2) antisense oligonucleotide in patients with advanced lymphoid malignancies. Up to 12 evaluable patients with a diagnosis of relapsed or refractory lymphoid malignancies are expected to participate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL)
- What is being tested?
- L-Bcl-2 antisense oligonucleotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Nov 2020to Apr 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Adults ≥18 years of age
- Patient has a life expectancy ≥ 3 month
- Patient has relapsed or refractory disease Relapsed lymphoma: Relapsed lymphoma is disease that has responded to treatment but then returns.
- Refractory lymphoma: Failure to achieve complete response at the end of therapy or progression within 6 months from completion of therapy
- Included Diseases
- DLBCL, including transformed lymphoma
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- Mantle Cell Lymphoma
- PTCL
- CTCL
- CLL/SLL
- Follicular lymphoma
- Marginal zone lymphoma
- Hodgkin lymphoma (both classical and lymphocyte predominant)
- Waldenströms Macroglobulinemia
- Must has failed or is not a candidate for available therapies with reasonable likelihood of clinical benefit, which includes FDA approved products and standard of care regimens
- Therapy means at least three front lines of therapy including Hematopoeitic Stem Cell Transplant (HSCT and/or Chimeric Antigen Receptor (CAR) T cells, when applicable
- Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study
- Males must agree to use an adequate method of contraception during the study
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1, or 2
- Adequate hepatic and renal functions as defined by:
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and
- Total bilirubin ≤1.5 times ULN; and
- Estimated glomerular filtration rate (eGFR) of at least 50ml/min. These estimations can be calculated using the following methods:
- Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation
- Cockcroft Gault equation
- Modification of Diet in Renal Disease (MDRD study equation)
- Creatinine clearance estimated by 24-hr urine collection for creatinine clearance
- Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment
- Willing and able to provide written informed consent
Who cannot join
- Active non-hematologic malignancy other than lymphoid malignancies treated with immuno- or chemotherapy within the previous 12 months except active non-melanoma, non-invasive skin cancer will be allowed
- Known, active Central Nervous System (CNS) involvement of disease requiring intrathecal therapy. Note: Patients with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening
- Patient eligible for high dose chemotherapy and autologous stem cell transplant
- Indolent non-Hodgkin lymphoma (iNHL)
- Patients at high risk of Tumor Lysis Syndrome (TLS)
- Bulky disease i. A unidimensional lesion greater than 10 cm and/or b. Lymphocyte count greater than 25,000 per µL
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- Receipt of any anti-cancer therapy within 14 days prior to Cycle 1 Day 1 (C1D1)
- Uncontrolled active, untreated, or progressive infection
- Receipt of any investigational agent or on study treatment within 30 days prior to C1D1
- Females who are pregnant, test positive for pregnancy, or are breast-feeding during the Screening period, or intend to become pregnant or breast-feed during the course of the study or within 30 days after last dose of study drug
- Serious intercurrent medical or psychiatric illness which, in the opinion of the Investigator, would interfere with the ability of the participant to complete the study
- Active hepatitis B infection (based on positive surface antigen [HBsAg]), hepatitis C infection (based on Hepatitis C Virus (HCV) positive antibody [HCV Ab]), or human immunodeficiency virus (HIV-1 or HIV-2, based on positive antibody)
- Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant baseline EKG abnormality (e.g., QTcF >470 msec)
- Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack
- Uncontrolled seizure disorder
- Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Georgia Cancer Center
Augusta, Georgia, 30912
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
MD Anderson Cancer Research Center
Houston, Texas, 77030
Sarah Cannon Research Institute/Tennesee Oncology
Nashville, Tennessee, 37203
New York Medical College / Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: A Phase 1 Clinical Trial to Study the Safety, Pharmacokinetics, and Efficacy of BP1002 (L-Bcl-2) Antisense Oligonucleotide in Patients With Advanced Lymphoid Malignancies
This study evaluates the safety, pharmacokinetics, and efficacy of BP1002 (L-Bcl-2) antisense oligonucleotide in patients with advanced lymphoid malignancies. Up to 12 evaluable patients with a diagnosis of relapsed or refractory lymphoid malignancies are expected to participate.
- Conditions
- Mantle Cell Lymphoma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma
- Being tested
- L-Bcl-2 antisense oligonucleotide
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Hodgkin Disease, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Bcl-2 antisense oligonucleotideDrug
Also called BP1002
There will be 2 planned dose levels, 20, and 40 mg/m^2. Successive cohorts of eligible patients with will be treated with BP1002. BP1002 is given as an intravenous infusion, twice weekly, as 8 doses per 28-day cycle. Cycles may be repeated every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BP1002 monotherapy | Experimental | L-Bcl-2 Antisense oligonucleotide (BP1002) is given in a sequential, dose escalation design. Starting dose is 20mg/m^2. Receives: Drug: L-Bcl-2 antisense oligonucleotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify Dose Limiting Toxicity (DLT) of BP1002
Identify DLT of BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria
Measured: 30 days
Identify and grade treatment-emergent adverse events (TEAE) of escalating doses of BP1002
Identify TEAE of BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria
Measured: 30 days
Identify and grade treatment-emergent laboratory abnormalities of escalating doses of BP1002 by identification and grading of
Identify and grade treatment-emergent laboratory abnormalities of BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria
Measured: 30 days
Identify conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in EKG intervals) of escalating doses of BP1002
Collection of 12-lead EKGs at defined intervals to identify conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in EKG intervals)
Measured: 30 days
Recommended Phase 2 dose (RP2D) of BP1002
Determine RP2D by evaluating Maximally Tolerated Dose (MTD) data: Any Dose Limiting Toxicity (DLT) observed will trigger an expansion of a cohort from 3 to 6 patients. A second DLT at any dose level will identify the Maximum Dose. The dose below that will be the MTD.
Measured: 210 days
Determine plasma pharmacokinetics (PK) of BP1002 using maximum plasma drug concentration
Evaluate in vivo PK of BP1002 using maximum plasma drug concentration (Cmax)
Measured: 30 days
Determine plasma pharmacokinetics (PK) of BP1002 using volume of distribution
Evaluate in vivo PK of BP1002 volume of distribution (Vd)
Measured: 30 days
Determine plasma pharmacokinetics (PK) of BP1002 using elimination rate constant
Evaluate in vivo PK of BP1002 elimination rate constant
Measured: 30 days
Determine half-life plasma pharmacokinetics (PK) of BP1002
Evaluate in vivo PK of BP1002 half-life (t1/2)
Measured: 30 days
Determine pharmacokinetics (PK) of BP1002
12-lead EKG assessments will be collected and analyzed for conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in EKG intervals) from those the EKG obtained immediately before the first BP1002 dose, and after BP1002 dose, and will mirror the time points used to collect the plasma PK assessments
Measured: 30 days
Secondary outcomes (6)
Determine evidence of tumor response by bone marrow aspirate
Assess tumor response by evaluating bone marrow aspirate to determine complete response (CR), partial response (PR), or minor response (MR) using appropriate uniform response criteria as published by Response Evaluation Criteria in Lymphoma (RECIL) 2017, CLL guidelines, and International Workshop on Waldenström's Macroglobulinemia (IWWM 6th)
Measured: 30 days
Determine evidence of tumor response by Complete Blood Count (CBC)
Assess tumor response by evaluating CBC measurements to determine complete response (CR), partial response (PR), or minor response (MR) using appropriate uniform response criteria as published by Response Evaluation Criteria in Lymphoma (RECIL) 2017, CLL guidelines, and International Workshop on Waldenström's Macroglobulinemia (IWWM 6th)
Measured: 30 days
Determine estimates for time to progression (TTP)
Measured from treatment start date to date of progression by CBC and/or bone marrow aspirate
Measured: 30 days
Determine estimates for progression-free survival (PFS)
Measured from treatment start date to date of progression or death by CBC and/or bone marrow aspirate
Measured: 30 days
Determine estimates for event-free survival (EFS)
Measured from treatment start date to date of progression, death, or change in therapy by CBC and/or bone marrow aspirate
Measured: 30 days
Activity of BP1002 on Bcl-2 expression in tumor samples
Flow cytometric assays to determine the effects of BP1002 on Bcl-2 protein expression using patient blood samples
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start5 Nov 2020
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-Path Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072458
- Sponsor's protocol ID
- BP1002-101-Lymph
- Status last verified
- Feb 2025
- First submitted
- 23 Aug 2019
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Study the Safety, Pharmacokinetics, and Efficacy of BP1002 (L-Bcl-2) Antisense Oligonucleotide in Patients With Advanced Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT04072458
- Acronym / sponsor ID
- BP1002-101-Lymph
- Conditions
- Mantle Cell Lymphoma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bio-Path Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 28 Aug 2019 (actual)
- 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.
This study evaluates the safety, pharmacokinetics, and efficacy of BP1002 (L-Bcl-2) antisense oligonucleotide in patients with advanced lymphoid malignancies. Up to 12 evaluable patients with a diagnosis of relapsed or refractory lymphoid malignancies are expected to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BP1002 monotherapy | Experimental | Drug: L-Bcl-2 antisense oligonucleotideL-Bcl-2 Antisense oligonucleotide (BP1002) is given in a sequential, dose escalation design. Starting dose is 20mg/m^2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Adults ≥18 years of age
- Patient has a life expectancy ≥ 3 month
- Patient has relapsed or refractory disease Relapsed lymphoma: Relapsed lymphoma is disease that has responded to treatment but then returns.
- Refractory lymphoma: Failure to achieve complete response at the end of therapy or progression within 6 months from completion of therapy
- Included Diseases
Key exclusion criteria (16 listed)
- Active non-hematologic malignancy other than lymphoid malignancies treated with immuno- or chemotherapy within the previous 12 months except active non-melanoma, non-invasive skin cancer will be allowed
- Known, active Central Nervous System (CNS) involvement of disease requiring intrathecal therapy. Note: Patients with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening
- Patient eligible for high dose chemotherapy and autologous stem cell transplant
- Indolent non-Hodgkin lymphoma (iNHL)
- Patients at high risk of Tumor Lysis Syndrome (TLS)
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 |
|---|---|---|
| L-Bcl-2 antisense oligonucleotideAlso: BP1002There will be 2 planned dose levels, 20, and 40 mg/m^2. Successive cohorts of eligible patients with will be treated with BP1002. BP1002 is given as an intravenous infusion, twice weekly, as 8 doses per 28-day cycle. Cycles may be repeated every 4 weeks. | Drug | BP1002 monotherapy |
Primary outcome
Identify Dose Limiting Toxicity (DLT) of BP1002
Time frame: 30 days
Identify DLT of BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria
Identify and grade treatment-emergent adverse events (TEAE) of escalating doses of BP1002
Time frame: 30 days
Identify TEAE of BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria
Identify and grade treatment-emergent laboratory abnormalities of escalating doses of BP1002 by identification and grading of
Time frame: 30 days
Identify and grade treatment-emergent laboratory abnormalities of BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria
Identify conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in EKG intervals) of escalating doses of BP1002
Time frame: 30 days
Collection of 12-lead EKGs at defined intervals to identify conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in EKG intervals)
Recommended Phase 2 dose (RP2D) of BP1002
Time frame: 210 days
Determine RP2D by evaluating Maximally Tolerated Dose (MTD) data: Any Dose Limiting Toxicity (DLT) observed will trigger an expansion of a cohort from 3 to 6 patients. A second DLT at any dose level will identify the Maximum Dose. The dose below that will be the MTD.
Determine plasma pharmacokinetics (PK) of BP1002 using maximum plasma drug concentration
Time frame: 30 days
Evaluate in vivo PK of BP1002 using maximum plasma drug concentration (Cmax)
Determine plasma pharmacokinetics (PK) of BP1002 using volume of distribution
Time frame: 30 days
Evaluate in vivo PK of BP1002 volume of distribution (Vd)
Determine plasma pharmacokinetics (PK) of BP1002 using elimination rate constant
Time frame: 30 days
Evaluate in vivo PK of BP1002 elimination rate constant
Determine half-life plasma pharmacokinetics (PK) of BP1002
Time frame: 30 days
Evaluate in vivo PK of BP1002 half-life (t1/2)
Determine pharmacokinetics (PK) of BP1002
Time frame: 30 days
12-lead EKG assessments will be collected and analyzed for conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in EKG intervals) from those the EKG obtained immediately before the first BP1002 dose, and after BP1002 dose, and will mirror the time points used to collect the plasma PK assessments
6 secondary outcomes
Determine evidence of tumor response by bone marrow aspirate
Time frame: 30 days
Determine evidence of tumor response by Complete Blood Count (CBC)
Time frame: 30 days
Determine estimates for time to progression (TTP)
Time frame: 30 days
Determine estimates for progression-free survival (PFS)
Time frame: 30 days
Determine estimates for event-free survival (EFS)
Time frame: 30 days
Activity of BP1002 on Bcl-2 expression in tumor samples
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-Bcl-2 antisense oligonucleotide in people with Mantle Cell Lymphoma and Peripheral T-cell Lymphoma (PTCL), run by Bio-Path Holdings, Inc. at 5 sites in United States.
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 29 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Identify Dose Limiting Toxicity (DLT) of BP1002 (time frame: 30 days). The study lists 10 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 24 Feb 2025.