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
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
Inclusion Criteria12
- \- 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 Criteria3
- 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.
Interventions
DRUGBMS-986369
Specified dose on specified days
Locations(40)
View Full Details on ClinicalTrials.gov
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NCT06035497