NCT06035497Active, not recruitingPhase 1/2
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)
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 83 (estimated)
- First submitted
- 28 Aug 2023
- Start date
- 20 Nov 2023
- Primary completion date
- 11 Aug 2026
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT06035497
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 83
- From 20 Nov 2023 to the primary completion date, 11 Aug 2026
- 40 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Other
- Have a life expectancy ≤ 3 months.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- \- Have one of the following subtypes of T-cell Lymphoma (TCL) with relapsed or refractory disease, as assessed by the investigator:.
- Adult T-cell leukemia-lymphoma (ATL).
- Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).
- Angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of T follicular helper phenotype (TFH) cell origin.
- Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase-positive (ALK+).
- ALCL, anaplastic lymphoma kinase-negative (ALK-).
- Breast implant-associated ALCL.
- Extranodal NK/T-cell lymphoma, nasal type (ENKL).
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.