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Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
Trial Status: active
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
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06792734.
Locations matching your search criteria
United States
North Carolina
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Status: Approved
Name Not Available
Winston-Salem
Wake Forest University Health Sciences
Status: Approved
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
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.
