RecruitingInterventionalPhase 1

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

NCT ID: NCT06792734Sponsor: Bantam PharmaceuticalsLast updated: 2025-09-18

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

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.

Arms & interventions

DrugBTM-3566
Oral Solution

Outcome measures

Primary

Adverse Event and dose-limiting toxicity event rates
The rate of adverse events and dose-limiting toxicity of therapy with BTM-3566
Time frame: 24 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (1)

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Luhua M Wang, MD · Contact

713-792-2121

Luhua M Wang, MD · Principal Investigator