Testing BTM-3566 for patients with relapsed or refractory mature B cell lymphomas
Phase 1A/1B Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
This study is testing a new drug called BTM-3566 to see if it can help adults with relapsed or hard-to-treat mature B cell lymphomas feel better and improve their condition.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bantam Pharmaceuticals Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06792734 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory mature B cell lymphoma and measurable disease.
Not a fit: Patients with primary CNS lymphoma or those with ongoing severe toxicities from previous treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat lymphomas.
How similar studies have performed: While this approach is novel for BTM-3566, similar trials with other agents have shown promise in treating relapsed or refractory lymphomas.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Lori McDermott
- Email: lmcdermott@bantampharma.com
- Phone: 1-646-598-4823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.