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
Additional locations may be listed on ClinicalTrials.gov for NCT06792734.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: 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.
Lead OrganizationBantam Pharmaceuticals
Principal InvestigatorZahid Bashir
