RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-02
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06792734

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * must be age ≥18 years
  2. * must have a diagnosis of relapsed or refractory mature B cell lymphoma
  3. * must have measurable disease per response evaluation criteria in lymphoma (Lugano classification)
  4. * must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  5. * must have a predicted life expectancy of ≥3 months
  6. * must agree to use adequate birth control throughout their participation and for 90 days following the last dose of BTM-3566
  1. * has primary CNS lymphoma
  2. * has ongoing toxicities from prior anti-cancer treatment \> Grade 1
  3. * has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation
  4. * has received any anti-cancer therapy (including radiation of curative intent) \<28 days prior to administration of BTM-3566
  5. * has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation).
  6. * is pregnant or breastfeeding

Contacts and Locations

Study Contact

Lori McDermott
CONTACT
1-646-598-4823
lmcdermott@bantampharma.com
Meghan Reynolds
CONTACT
mreynolds@bantampharma.com

Principal Investigator

Zahid Bashir, MBBS
STUDY_DIRECTOR
Bantam Pharmaceuticals

Study Locations (Sites)

MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Bantam Pharmaceuticals

  • Zahid Bashir, MBBS, STUDY_DIRECTOR, Bantam Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-02
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphoma, B-Cell