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A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies

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

NCT04072458•Bio-Path Holdings, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults ≥18 years of age
•2. Patient has a life expectancy ≥ 3 month
•3. 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
•4. Included Diseases
•* DLBCL, including transformed lymphoma
•* Mantle Cell Lymphoma
•* PTCL
•* CTCL
•* CLL/SLL
+19 more criteria

Exclusion Criteria

•1. 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
•2. 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
•3. Patient eligible for high dose chemotherapy and autologous stem cell transplant
•4. Indolent non-Hodgkin lymphoma (iNHL)
•5. Patients at high risk of Tumor Lysis Syndrome (TLS)
•a. Bulky disease i. A unidimensional lesion greater than 10 cm and/or b. Lymphocyte count greater than 25,000 per µL
•6. Receipt of any anti-cancer therapy within 14 days prior to Cycle 1 Day 1 (C1D1)
•7. Uncontrolled active, untreated, or progressive infection
•8. Receipt of any investigational agent or on study treatment within 30 days prior to C1D1
•9. 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
+6 more criteria

Locations (5)

Georgia Cancer Center

Augusta, Georgia, United States

New York Medical College / Westchester Medical Center

Valhalla, New York, United States

Sarah Cannon Research Institute/Tennesee Oncology

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Research Center

Houston, Texas, United States

Key Dates

Start Date

November 5, 2020

Primary Completion Date

April 1, 2025

Completion Date

April 1, 2025

Last Updated

February 24, 2025

Enrollment

ESTIMATED participants

Conditions

Mantle Cell LymphomaPeripheral T-cell Lymphoma (PTCL)Cutaneous T-cell Lymphoma (CTCL)Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)Follicular LymphomaMarginal Zone LymphomaHodgkin LymphomaWaldenstrom MacroglobulinemiaDLBCL

Interventions

L-Bcl-2 antisense oligonucleotide

DRUG

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

NCT06263491

Mantle Cell Lymphoma

View study

RECRUITINGPHASE2

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

A Long-term Extension Study of PCI-32765 (Ibrutinib)