Recruiting
Phase 1

BTM-3566

Sponsor:

Bantam Pharmaceuticals

Code:

NCT06792734

Conditions

Lymphoma, B-Cell

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BTM-3566

Study Details

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

Study ID

NCT06792734

Start date

Feb 14, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BTM-3566 Treatment

BTM-3566 Oral Solution

Interventions

BTM-3566

Oral Solution

Primary outcome measure

  • Adverse Event and dose-limiting toxicity event rates [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Lori McDermott

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

Meghan Reynolds

mreynolds@bantampharma.com

Locations

Levine Cancer Institute, Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Phase 1 Oncology Research Nurse

800-804-9376Alexandra.M.White@advocatehealth.org

Principal Investigator:

Steven Park

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Luhua M Wang, MD

713-792-2121

Principal Investigator:

Luhua M Wang, MD

More Information

Sponsor

Bantam Pharmaceuticals

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bantam Pharmaceuticals on 2026-07-07.