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)

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Relapsed or Refractory T-cell Lymphomas

Treatments

Drug: BMS-986369

Study type

Interventional

Funder types

Industry

Identifiers

NCT06035497

CA073-1008

Details and patient eligibility

About

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).

Enrollment

85 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.