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

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

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

Study Overview

• Status: Recruiting
• Conditions: Lymphoma, B-Cell
• Intervention / Treatment: Drug: BTM-3566

Detailed Description

This is an open label, phase 1 dose escalation trial of BTM-3566 in relapsed/refractory mature b cell lymphomas. Dose escalation will utilize traditional 3+3 methodology to determine the maximum tolerated dose of BTM-3566. Treatment will be given as two-week cycles, with BTM-3566 taken daily during the first week of the cycle, and the second week 'off therapy'. DLT window will be the first two cycles of therapy (days 1 to 28). All enrolled patients will undergo a baseline FDG-PET/CT scan within 3 weeks prior to starting therapy. FDG-PET/CT will be repeated at the start of Cycles 3 and 5 or more frequently as clinically indicated. Beginning at Cycle 5, imaging will be repeated every 3 months (or as clinically indicated) for up to 12 months, and every 6 months thereafter, until disease progression or start of subsequent anti-cancer therapy.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lori McDermott; Phone Number: 1-646-598-4823; Email: lmcdermott@bantampharma.com
• Study Contact Backup: Name: Meghan Reynolds; Email: mreynolds@bantampharma.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Luhua M Wang, MD; Phone Number: 713-792-2121
      • Principal Investigator: Luhua M Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BTM-3566 Treatment; BTM-3566 Oral Solution	Drug: BTM-3566; Oral Solution; Other Names: BTM-3566 Oral Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event and dose-limiting toxicity event rates	The rate of adverse events and dose-limiting toxicity of therapy with BTM-3566	24 months

Collaborators and Investigators

• Sponsor: Bantam Pharmaceuticals
• Investigators: Study Director: Zahid Bashir, MBBS, Bantam Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, B-Cell
• Other Study ID Numbers: BTM-3566-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No