A Phase 1/2 Study of BMS-986369(Golcadomide)in Participants with Relapsed or Refractory T-cell Lymphomasin Japan

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061230061

Enrollment

Registered

2023-09-27

Start date

2023-11-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or Refractory T-cell Lymphoma

Interventions

Drug: BMS-986369(Other Names:Golcadomide/CC-99282) Specified dose on specified days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Have T-cell Lymphoma with relapsed or refractory disease, as assessed by the investigator - 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

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.

Design outcomes

Primary

Measure	Time frame
Phase 1: To assess the safety and tolerability and establish the RP2D of BMS-986369 in participants with R/R TCL. Phase 2 (ATL cohort): To assess the efficacy of BMS-986369 in participants with R/R ATL. Phase 2 (PTCL cohort): To assess the efficacy of BMS-986369 in participants with R/R PTCL.	—

Secondary

Measure	Time frame
- To characterize the PK of BMS-986369 in participants with R/R TCL. - To assess the preliminary efficacy of BMS-986369 in participants with R/R TCL. - To assess the safety and tolerability of BMS-986369 in participants with R/R ATL and R/R PTCL. - To characterize the PK of BMS-986369 in participants with R/R ATL and R/R PTCL. - To assess the efficacy parameters of BMS-986369 including ORR (investigator assessment), DCR, CR rate, TTR, DOR, PFS, TTNT, and OS in participants with R/R ATL and R/R PTCL.	—

Measure

Time frame

- To characterize the PK of BMS-986369 in participants with R/R TCL. - To assess the preliminary efficacy of BMS-986369 in participants with R/R TCL. - To assess the safety and tolerability of BMS-986369 in participants with R/R ATL and R/R PTCL. - To characterize the PK of BMS-986369 in participants with R/R ATL and R/R PTCL. - To assess the efficacy parameters of BMS-986369 including ORR (investigator assessment), DCR, CR rate, TTR, DOR, PFS, TTNT, and OS in participants with R/R ATL and R/R PTCL.

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Contacts

Public ContactRyosuke Naka

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026