Actively Recruiting
Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
Led by Bantam Pharmaceuticals · Updated on 2025-09-18
24
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be age 18 years or older
- Must have a diagnosis of relapsed or refractory mature B cell lymphoma
- Must have measurable disease according to response evaluation criteria in lymphoma (Lugano classification)
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Must have a predicted life expectancy of at least 3 months
- Must agree to use adequate birth control during the study and for 90 days after the last dose of BTM-3566
You will not qualify if you...
- Has primary central nervous system lymphoma
- Has ongoing toxicities greater than Grade 1 from prior anti-cancer treatment
- 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) within 28 days before starting BTM-3566
- Has a current second malignancy at other sites except non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation
- Is pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Lori McDermott
CONTACT
M
Meghan Reynolds
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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