Clinical trial NCT06792734: Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
Official title: Phase 1A/1B Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lymphoma, B-Cell
Lead sponsor: Bantam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Adverse Event and dose-limiting toxicity event rates
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Bantam Pharmaceuticals
name: Zahid Bashir, MBBS
role: STUDY_DIRECTOR
References: