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

NCT06792734 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BTM-3566-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphoma, B-Cell

Outcome Measures

Primary Outcomes (1)

• Adverse Event and dose-limiting toxicity event rates

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

  24 months

Study Arms (1)

BTM-3566 Treatment

EXPERIMENTAL

BTM-3566 Oral Solution

Drug: BTM-3566

Interventions

BTM-3566 DRUG

Oral Solution

Also known as: BTM-3566 Oral Solution

BTM-3566 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bantam Pharmaceuticals: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Zahid Bashir, MBBS

  Bantam Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Lori McDermott

CONTACT

1-646-598-4823; lmcdermott@bantampharma.com

Meghan Reynolds

CONTACT

mreynolds@bantampharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: February 14, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)