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

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

Conditions

Lymphoma, B-Cell

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Lymphoma, B-Cell
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bantam Pharmaceuticals,

Zahid Bashir, MBBS, STUDY_DIRECTOR, Bantam Pharmaceuticals

Study Record Dates

2027-12