Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
ConditionLymphoma, B-Cell
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBantam Pharmaceuticals
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- BTM-3566
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov