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Phase 1 Trial of BTM-3566 for Relapsed/Refractory Mature B Cell Lymphomas

This study is testing a new oral medicine called BTM-3566 for adults with mature B cell lymphoma that has come back (relapsed) or hasn't responded to previous treatments (refractory). The main goals are to find out what side effects BTM-3566 might cause at different doses, how much of the medicine gets into the blood, and how well it works to slow or stop the cancer. You might be able to join if you are at least 18 years old, have measurable lymphoma, and a good enough general health status. The study aims to enroll 24 participants. The current status of this trial is unclear.

Study design
This is a Phase 1, open-label study involving approximately 24 participants. It uses a dose escalation method to find the safest and most effective dose of BTM-3566.
What's involved
You will take BTM-3566 in two-week cycles, with medicine taken for 7 days and then 7 days off. You will have regular clinic visits for checkups and tests, and keep a diary of your dosing and weight.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects for up to 24 months. Imaging will be repeated every 3 months after Cycle 5 for up to 12 months, and then every 6 months until disease progression or other treatment starts.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06792734

Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bantam Pharmaceuticals
~24 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:BTM-3566

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Event and dose-limiting toxicity event rates
Measured over 24 months

Conditions

Lymphoma, B-Cell

Explore related trials

Mature B-Cell Non-Hodgkin Lymphoma

NCT06792734

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Levine Cancer Institute, Atrium Health

    Charlotte, North Carolinastudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Glen Weiss, MD · STUDY_DIRECTOR · Bantam Pharmaceuticals

Who to contact

Lori McDermott
[email protected]
1-646-598-4823
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Adverse Event and dose-limiting toxicity event rates24 months

    The rate of adverse events and dose-limiting toxicity of therapy with BTM-3566