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)
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Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
85estimated
Sites
40
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-11-20 | actual | When the study began enrolling |
| Primary completion | 2027-01-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-10-10 | estimated | The whole study's end, after follow-up |
| First posted | 2023-09-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Relapsed or Refractory T-cell Lymphomas
Intervention
- Drug: BMS-986369 — also filed as Golcadomide, CC-99282
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with Adverse Events (AEs)
measured Up to 5 weeks after last dose of treatment
Number of participants with treatment-emergent adverse events (TEAEs)
measured Up to 5 weeks after last dose of treatment
Number of participants with Dose-Limiting Toxicity (DLT)
measured Up to 28 days after first dose
Number of participants with laboratory abnormalities
measured Up to 5 weeks after last dose of treatment
Number of participants with vital sign abnormalities
measured Up to 5 weeks after last dose of treatment
Number of participants with Electrocardiogram (ECG) abnormalities
measured Up to 5 weeks after last dose of treatment
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
measured Up to 5 weeks after last dose of treatment
Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities
measured Up to 5 weeks after last dose of treatment
Number of participants with Physical Examination (PE) abnormalities
measured Up to 5 weeks after last dose of treatment
Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL
measured Up to 2 years after last does of treatment
Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based)
measured Up to 2 years after last dose of treatment
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