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)

Launched by BRISTOL-MYERS SQUIBB · Sep 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called BMS-986369 to see how safe it is, how well it works, and how much of the drug gets into the body in people with certain types of T-cell lymphomas that have come back or have not responded to previous treatments. T-cell lymphomas are a type of cancer that affects the immune system, and the trial is taking place in Japan. The researchers are looking for participants aged 65 to 74 who have specific types of T-cell lymphoma and have not had success with standard treatments.

Participants in the study can expect to receive the new drug and will be closely monitored for any side effects or changes in their condition. To be eligible, they should have already tried at least one other treatment and should not have any serious health issues that would prevent their participation. It's important to know that this is the first phase of testing, which means the study is primarily focused on understanding the safety of the drug before it can be tested more widely.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • - Have one of the following subtypes of T-cell Lymphoma (TCL) with relapsed or refractory disease, as assessed by the investigator:.
• • i) Adult T-cell leukemia-lymphoma (ATL).
• • ii) Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).
• • iii) Angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of T follicular helper phenotype (TFH) cell origin.
• • iv) Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase-positive (ALK+).
• • v) ALCL, anaplastic lymphoma kinase-negative (ALK-).
• • vi) Breast implant-associated ALCL.
• • vii) Extranodal NK/T-cell lymphoma, nasal type (ENKL).
• • viii) Mycosis fungoides (MF) with advanced stage (stage IIB-IVB).
• • Phase 1 participants must not be responsive, intolerant, or ineligible to standard therapies that may prolong life or provide symptomatic relief, or for whom no standard therapeutic option is available in the clinical practice guidelines in the opinion of the investigator.
• • Phase 2 participants must have been treated by at least 1 prior line of systemic therapy.
• • Have an Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
• • Exclusion Criteria
• • Have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study.
• • Have any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participants at unacceptable risk if he/she were to participate in the study.
• • Have a life expectancy ≤ 3 months.
• • Other protocol-defined Inclusion/Exclusion criteria apply.