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NCT Number: NCT06035497

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)

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).

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This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986369

Drug

Specified dose on specified days

Other names: Golcadomide, CC-99282

Primary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 1 participants

  2. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 1 participants

  3. Number of participants with Dose-Limiting Toxicity (DLT)

    Time frame: Up to 28 days after first dose

    Phase 1 participants

  4. Number of participants with laboratory abnormalities

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 1 participants

  5. Number of participants with vital sign abnormalities

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 1 participants

  6. Number of participants with Electrocardiogram (ECG) abnormalities

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 1 participants

  7. Eastern Cooperative Oncology Group Performance Status (ECOG PS)

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 1 participants

  8. Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 1 participants

  9. Number of participants with Physical Examination (PE) abnormalities

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 1 participants

  10. Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL

    Time frame: Up to 2 years after last does of treatment

    Phase 2: Adult T-cell Leukemia-Lymphoma (ATL) cohort

    OR is defined as the achievement of Partial Response (PR), complete response unconfirmed (CRu), or Complete Response (CR)

  11. Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based)

    Time frame: Up to 2 years after last dose of treatment

    Phase 2: Peripheral T-cell Lymphoma (PTCL) cohort

    OR is defined as the achievement of PR or CR

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)

  2. Area under the plasma concentration time-curve (AUC)

    Time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)

  3. Time to peak (maximum) plasma concentration (Tmax)

    Time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)

  4. Number of participants with AEs

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 2 participants

  5. Number of participants with TEAEs

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 2 participants

  6. Number of participants with laboratory abnormalities

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 2 participants

  7. Number of participants with vital sign abnormalities

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 2 participants

  8. Number of participants with ECG abnormalities

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 2 participants

  9. ECOG PS

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 2 participants

  10. Number of participants with LVEF assessment abnormalities

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 2 participants

  11. Number of participants with PE abnormalities

    Time frame: Up to 5 weeks after last dose of treatment

    Phase 2 participants

  12. Number of participants who achieve OR as assessed by central review per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL participants

    OR is defined as the achievement of PR, CRu, or CR

  13. Number of participants who achieve OR as assessed by investigator per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL participants

    OR is defined as the achievement of PR, CRu, or CR

  14. Number of participants who achieve OR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based).

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

    OR is defined as the achievement of PR or CR

  15. Number of participants who achieve OR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based).

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

    OR is defined as the achievement of PR or CR

  16. Number of participants who achieve disease control as assessed by central review per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL participants

    Disease control is considered to be stable disease (SD), PR, CRu, or CR

  17. Number of participants who achieve disease control as assessed by investigator per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL participants

    Disease control is considered to be SD, PR, CRu, or CR

  18. Number of participants who achieve CR as assessed by central review per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL participants

  19. Number of participants who achieve CR as assessed by investigator per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL participants

  20. Time to response (TTR) as assessed by central review per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL participants

  21. TTR as assessed by investigator per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL participants

  22. Duration of response (DOR) as assessed by central review per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL Participants

  23. DOR as assessed by investigator per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL Participants

  24. Progression Free Survival (PFS) as assessed by central review per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL participants

  25. PFS as assessed by investigator per international consensus response criteria for ATL

    Time frame: Up to 4 years after last dose of treatment

    ATL participants

  26. Number of participants who achieve disease control as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

    Disease control is considered to be SD, PR or CR

  27. Number of participants who achieve disease control as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

    Disease control is considered to be SD, PR or CR

  28. Number of participants who achieve CR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

  29. Number of participants who achieve CR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

  30. TTR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

  31. TTR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

  32. DOR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

  33. DOR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

  34. PFS as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

  35. PFS as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)

    Time frame: Up to 4 years after last dose of treatment

    PTCL participants

  36. Time to next treatment (TTNT)

    Time frame: From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, time to next treatment or the end of the trial, whichever occurs first, assessed up to 2 years after end of treatment.

  37. Overall survival (OS)

    Time frame: From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, or the end of the trial, whichever occurs first, assessed up to 2 years after end of treatment.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2027
Study completion
2030
First posted
Sep 13, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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