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Assessing Golcadomide for T-cell Lymphomas in 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)

Phase1; Phase2 Interventional Bristol-Myers Squibb · NCT06035497

This study is testing a new drug called Golcadomide to see if it can help people in Japan with hard-to-treat T-cell lymphomas feel better.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment85 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations40 sites (Anjo-shi, Aichi and 39 other locations)
Trial IDNCT06035497 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, efficacy, and drug levels of BMS-986369 (Golcadomide) in patients with relapsed or refractory T-cell lymphomas in Japan. Participants will be assessed for various subtypes of T-cell lymphoma, including Adult T-cell leukemia-lymphoma and Peripheral T-cell lymphoma. The study is conducted in two phases, with Phase 1 focusing on those who are unresponsive or intolerant to standard therapies, while Phase 2 will include participants with specific eligibility criteria. The goal is to determine the effectiveness of Golcadomide in this patient population.

Who should consider this trial

Good fit: Ideal candidates are individuals with relapsed or refractory T-cell lymphomas who have exhausted standard treatment options.

Not a fit: Patients with early-stage T-cell lymphomas or those who are responsive to standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat T-cell lymphomas.

How similar studies have performed: While there have been studies on T-cell lymphomas, the specific use of Golcadomide in this context is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

- 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 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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Anjo-shi, Aichi and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed or Refractory T-cell LymphomasRelapsed or Refractory Peripheral T-cell LymphomaRelapsed or Refractory Adult T-cell Leukemia/LymphomaGolcadomideBMS-986369CC-99282Adult T-cell leukemia/lymphomaPeripheral T-cell lymphoma, not otherwise specified
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.