RecruitingPhase 1Phase 2NCT06035497

A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)

A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)

Sponsor

Bristol-Myers Squibb

Enrollment

85 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory T-cell Lymphomas

Summary

The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of BMS-986369 (Golcadomide) in participants with relapsed or refractory T-cell lymphomas in Japan (GOLSEEK-3).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called golcadomide (BMS-986369) in Japanese patients with relapsed or refractory T-cell lymphoma — a group of blood cancers involving abnormal T-cells — that has come back or stopped responding to treatment. **You may be eligible if...** - You have one of several specific subtypes of T-cell lymphoma (including ATL, PTCL, AITL, ALCL, mycosis fungoides stage IIB–IVB, or others) - Your cancer has relapsed or is no longer responding to treatment - You have received at least one prior treatment (for Phase 2 participants) - You are in reasonably good functional health (ECOG 0–2) - You are enrolled and treated in Japan **You may NOT be eligible if...** - Your life expectancy is 3 months or less - You have a significant uncontrolled medical condition or active infection - You have laboratory values outside acceptable ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBMS-986369

Specified dose on specified days

Locations(40)

Anjo Kosei Hospital

Anjo-shi, Aichi-ken, Japan

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, Japan

Kameda General Hospital

Kamogawa, Chiba, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

International University of Health and Welfare Narita Hospital

Narita, Chiba, Japan

Aso Iizuka Hospital

Iizuka, Fukuoka, Japan

Japan Community Healthcare Organization Kyushu Hospital

Kitakyushu-shi, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, Hyōgo, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Yokosukakyosai

Yokosuka, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

National Hospital Organization Nagasaki Medical Center

Ōmura, Nagasaki, Japan

Sasebo City General Hospital

Sasebo, Nagasaki, Japan

Kindai University Hospital- Osakasayama Campus

Ōsaka-sayama, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Nihon University Itabashi Hospital

Itabashiku, Tokyo, Japan

Japanese Foundation for Cancer Research

Koto, Tokyo, Japan

The Jikei University Hospital

Minato-ku, Tokyo, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Japan

Fukuoka University Hospital

Fukuoka, Japan

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, Japan

Hiroshima University Hospital

Hiroshima, Japan

Imamura General Hospital

Kagoshima, Japan

Kagoshima University Hospital

Kagoshima, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan

Kumamoto University

Kumamoto, Japan

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, Japan

Kyorin University Hospital

Mitaka, Japan

University of Miyazaki Hospital

Miyazaki, Japan

The Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, Japan

Okayama University Hospital

Okayama, Japan

Nakagami Hospital Okinawa

Okinawa, Japan

Osaka International Cancer Institute

Osaka, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Oita Prefectural Hospital

Ōita, Japan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06035497