A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies

Last updated: February 21, 2025
Sponsor: Bio-Path Holdings, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoma

Marginal Zone Lymphoma

Follicular Lymphoma

Treatment

L-Bcl-2 antisense oligonucleotide

Clinical Study ID

NCT04072458
BP1002-101-Lymph
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 isdisease that has responded to treatment but then returns. Refractory lymphoma: Failure to achieve complete response at the end of therapy orprogression within 6 months from completion of therapy

  4. Included Diseases

  • DLBCL, including transformed lymphoma

  • Mantle Cell Lymphoma

  • PTCL

  • CTCL

  • CLL/SLL

  • Follicular lymphoma

  • Marginal zone lymphoma

  • Hodgkin lymphoma (both classical and lymphocyte predominant)

  • Waldenströms Macroglobulinemia

  1. Must has failed or is not a candidate for available therapies with reasonablelikelihood of clinical benefit, which includes FDA approved products and standard ofcare regimens

  2. Therapy means at least three front lines of therapy including Hematopoeitic StemCell Transplant (HSCT and/or Chimeric Antigen Receptor (CAR) T cells, whenapplicable

  3. Females must be of non-childbearing potential, surgically sterile, postmenopausal,or practice adequate methods of contraception during the study

  4. Males must agree to use an adequate method of contraception during the study

  5. Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1, or 2

  6. Adequate hepatic and renal functions as defined by:

  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times theupper limit of normal (ULN); and

  • Total bilirubin ≤1.5 times ULN; and

  • Estimated glomerular filtration rate (eGFR) of at least 50ml/min. Theseestimations 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 creatinineclearance

  1. Recovered from the effects of any prior surgery, radiotherapy, or antineoplastictreatment (with the exception of alopecia), based on Investigator assessment

  2. Willing and able to provide written informed consent

Exclusion

Exclusion Criteria:

  1. Active non-hematologic malignancy other than lymphoid malignancies treated withimmuno- 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 requiringintrathecal therapy. Note: Patients with a history of CNS disease may be allowed toparticipate 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. Lymphocytecount 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 toC1D1

  9. Females who are pregnant, test positive for pregnancy, or are breast-feeding duringthe Screening period, or intend to become pregnant or breast-feed during the courseof the study or within 30 days after last dose of study drug

  10. Serious intercurrent medical or psychiatric illness which, in the opinion of theInvestigator, would interfere with the ability of the participant to complete thestudy

  11. Active hepatitis B infection (based on positive surface antigen [HBsAg]), hepatitisC infection (based on Hepatitis C Virus (HCV) positive antibody [HCV Ab]), or humanimmunodeficiency virus (HIV-1 or HIV-2, based on positive antibody)

  12. Presence of concurrent conditions that, in the opinion of the Investigator and/orMedical Monitor, may compromise or interfere with any aspect of study conduct orinterpretation of results. This includes, but is not limited to, unstable oruncontrolled angina, New York Heart Association (NYHA) class III or IV congestiveheart failure, uncontrolled and sustained hypertension, clinically significantcardiac dysrhythmia or clinically significant baseline EKG abnormality (e.g., QTcF >470 msec)

  13. Within the past 6 months, has had any of the following: myocardial infarction,unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascularaccident or transient ischemic attack

  14. Uncontrolled seizure disorder

  15. Unable or unwilling to communicate or cooperate with the Investigator or follow theprotocol for any reason.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: L-Bcl-2 antisense oligonucleotide
Phase: 1
Study Start date:
November 05, 2020
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Georgia Cancer Center

    Augusta, Georgia 30912
    United States

    Site Not Available

  • New York Medical College / Westchester Medical Center

    Valhalla, New York 10595
    United States

    Site Not Available

  • Westchester Medical Center

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute/Tennesee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • MD Anderson Cancer Research Center

    Houston, Texas 77030
    United States

    Site Not Available

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