NCT06792734 Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
| NCT ID | NCT06792734 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Bantam Pharmaceuticals |
| Condition | Lymphoma, B-Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-02-14 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-02-14 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Zahid Bashir, MBBS
STUDY DIRECTOR
Bantam Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06792734 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma, B-Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06792734 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06792734 currently recruiting?
Yes, NCT06792734 is actively recruiting participants. Contact the research team at lmcdermott@bantampharma.com for enrollment information.
Where is the NCT06792734 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06792734 clinical trial?
NCT06792734 is sponsored by Bantam Pharmaceuticals. The principal investigator is Zahid Bashir, MBBS at Bantam Pharmaceuticals. The trial plans to enroll 24 participants.