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

JRCT ID: jRCT2061230061

Registered date:27/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Relapsed or Refractory T-cell Lymphoma
• Date of first enrollment: 27/09/2023
• Target sample size: 85
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

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 Outcome

- 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hayakawa Jin