Testing BTM-3566 for patients with relapsed or refractory mature B cell lymphomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of BTM-3566 in adult patients diagnosed with relapsed or refractory mature B cell lymphomas. It employs a phase 1 dose escalation methodology to determine the maximum tolerated dose while monitoring side effects and clinical benefits. Participants will receive BTM-3566 in cycles of 14 days, with daily dosing for the first week followed by a week off therapy, and will undergo regular checkups and imaging to assess disease progression. The study will also track the levels of the drug in the blood at various time points.

Why it matters

Who can join: the full rules

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

Where it's running

• Levine Cancer Institute, Atrium Health
  Charlotte, North Carolina, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Lori McDermott
• Email: lmcdermott@bantampharma.com
• Phone: 1-646-598-4823

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.