Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06792734 | RECRUITING | Lymphoma, B-Cell

Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
Sponsor:

Bantam Pharmaceuticals

Brief Summary:

The goal of this clinical trial is to learn if BMT-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas. It will also learn how well BTM-3566 works to treat relapsed or refractory mature b cell lymphomas. The main questions it aims to answer are: What are the side effects of BTM-3566 at different doses? What are the levels of BTM-3566 in the blood at different timepoints around dosing? What is the clinical benefit of BTM-3566 in treating cancer (i.e. how well does it slow or stop disease progression)? Participants will: Take BTM-3566 in 14-day periods with 7 days of dosing followed by 7 days of no dosing Visit the clinic regularly for checkups and tests Keep a diary of their dosing and weight

Condition or disease

Lymphoma, B-Cell

Intervention/treatment

BTM-3566

Phase

PHASE1

Detailed Description:

This is an open label, phase 1 dose escalation trial of BTM-3566 in relapsed/refractory mature b cell lymphomas. Dose escalation will utilize traditional 3+3 methodology to determine the maximum tolerated dose of BTM-3566. Treatment will be given as two-week cycles, with BTM-3566 taken daily during the first week of the cycle, and the second week 'off therapy'. DLT window will be the first two cycles of therapy (days 1 to 28). All enrolled patients will undergo a baseline FDG-PET/CT scan within 3 weeks prior to starting therapy. FDG-PET/CT will be repeated at the start of Cycles 3 and 5 or more frequently as clinically indicated. Beginning at Cycle 5, imaging will be repeated every 3 months (or as clinically indicated) for up to 12 months, and every 6 months thereafter, until disease progression or start of subsequent anti-cancer therapy.

Study Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase 1A/1B Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
Actual Study Start Date : 2025-02-14
Estimated Primary Completion Date : 2027-02
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * must be age ≥18 years
  • * must have a diagnosis of relapsed or refractory mature B cell lymphoma
  • * must have measurable disease per response evaluation criteria in lymphoma (Lugano classification)
  • * must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • * must have a predicted life expectancy of ≥3 months
  • * must agree to use adequate birth control throughout their participation and for 90 days following the last dose of BTM-3566
Exclusion Criteria
  • * has primary CNS lymphoma
  • * has ongoing toxicities from prior anti-cancer treatment \> Grade 1
  • * has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation
  • * has received any anti-cancer therapy (including radiation of curative intent) \<28 days prior to administration of BTM-3566
  • * has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation).
  • * is pregnant or breastfeeding
Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas

Location Details

NCT06792734

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030