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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed or Refractory T-cell Lymphomas
• Intervention / Treatment: Drug: BMS-986369

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 810-8563
    • Local Institution - 0018
  • Fukuoka, Japan, 812-8582
    • Local Institution - 0012
  • Fukuoka, Japan, 814-0180
    • Local Institution - 0023
  • Hiroshima, Japan, 730-0052
    • Local Institution - 0039
  • Hiroshima, Japan, 7348551
    • Local Institution - 0025
  • Kagoshima, Japan, 890-8520
    • Local Institution - 0008
  • Kagoshima, Japan, 890-0064
    • Local Institution - 0015
  • Kumamoto, Japan, 860-8556
    • Local Institution - 0006
  • Kumamoto, Japan, 860-0008
    • Local Institution - 0035
  • Kyoto, Japan, 602-8566
    • Local Institution - 0027
  • Mitaka, Japan, 181-8611
    • Local Institution - 0022
  • Miyazaki, Japan, 889-1692
    • Local Institution - 0038
  • Nagasaki, Japan, 852-8104
    • Local Institution - 0030
  • Okayama, Japan, 700-8558
    • Local Institution - 0007
  • Okinawa, Japan, 904-2142
    • Local Institution - 0042
  • Osaka, Japan, 541-8567
    • Local Institution - 0010
  • Osaka, Japan, 545-8586
    • Local Institution - 0034
  • Ōita, Japan, 870-8511
    • Local Institution - 0020
  • Aichi-ken
    • Anjo-shi, Aichi-ken, Japan, 446-8602
      • Local Institution - 0031
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Local Institution - 0011
    • Toyohashi, Aichi-ken, Japan, 441-8570
      • Local Institution - 0024
  • Chiba
    • Kamogawa, Chiba, Japan, 296-0041
      • Local Institution - 0017
    • Kashiwa, Chiba, Japan, 277-8577
      • Local Institution - 0002
    • Narita, Chiba, Japan, 286-8520
      • Local Institution - 0037
  • Fukuoka
    • Iizuka, Fukuoka, Japan, 820-8505
      • Local Institution - 0016
    • Kitakyushu-shi, Fukuoka, Japan, 806-8501
      • Local Institution - 0041
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 0608648
      • Local Institution - 0036
  • Hyōgo
    • Amagasaki, Hyōgo, Japan, 660-8550
      • Local Institution - 0032
    • Kobe, Hyōgo, Japan, 650-0047
      • Local Institution - 0033
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Local Institution - 0004
    • Yokosuka, Kanagawa, Japan, 238-8558
      • Local Institution - 0013
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Local Institution - 0001
  • Nagasaki
    • Sasebo, Nagasaki, Japan, 857-8511
      • Local Institution - 0028
    • Ōmura, Nagasaki, Japan, 8568562
      • Local Institution - 0019
  • Osaka
    • Ōsaka-sayama, Osaka, Japan, 589-8511
      • Local Institution - 0005
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Local Institution - 0009
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Local Institution - 0003
    • Itabashiku, Tokyo, Japan, 173-8610
      • Local Institution - 0029
    • Koto, Tokyo, Japan, 135-8550
      • Local Institution - 0040
    • Minato-ku, Tokyo, Japan, 105-8471
      • Local Institution - 0026

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of BMS-986369	Drug: BMS-986369; Specified dose on specified days; Other Names: Golcadomide; CC-99282

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events (AEs)	Phase 1 participants	Up to 5 weeks after last dose of treatment
Number of participants with treatment-emergent adverse events (TEAEs)	Phase 1 participants	Up to 5 weeks after last dose of treatment
Number of participants with Dose-Limiting Toxicity (DLT)	Phase 1 participants	Up to 28 days after first dose
Number of participants with laboratory abnormalities	Phase 1 participants	Up to 5 weeks after last dose of treatment
Number of participants with vital sign abnormalities	Phase 1 participants	Up to 5 weeks after last dose of treatment
Number of participants with Electrocardiogram (ECG) abnormalities	Phase 1 participants	Up to 5 weeks after last dose of treatment
Eastern Cooperative Oncology Group Performance Status (ECOG PS)	Phase 1 participants	Up to 5 weeks after last dose of treatment
Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities	Phase 1 participants	Up to 5 weeks after last dose of treatment
Number of participants with Physical Examination (PE) abnormalities	Phase 1 participants	Up to 5 weeks after last dose 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)	Phase 2: Peripheral T-cell Lymphoma (PTCL) cohort OR is defined as the achievement of PR or CR	Up to 2 years 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	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)	Up to 2 years after last does of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax)		Up to Day 8 of Cycle 2 (each cycle is 28 days)
Area under the plasma concentration time-curve (AUC)		Up to Day 8 of Cycle 2 (each cycle is 28 days)
Time to peak (maximum) plasma concentration (Tmax)		Up to Day 8 of Cycle 2 (each cycle is 28 days)
Number of participants with AEs	Phase 2 participants	Up to 5 weeks after last dose of treatment
Number of participants with TEAEs	Phase 2 participants	Up to 5 weeks after last dose of treatment
Number of participants with laboratory abnormalities	Phase 2 participants	Up to 5 weeks after last dose of treatment
Number of participants with vital sign abnormalities	Phase 2 participants	Up to 5 weeks after last dose of treatment
Number of participants with ECG abnormalities	Phase 2 participants	Up to 5 weeks after last dose of treatment
ECOG PS	Phase 2 participants	Up to 5 weeks after last dose of treatment
Number of participants with LVEF assessment abnormalities	Phase 2 participants	Up to 5 weeks after last dose of treatment
Number of participants with PE abnormalities	Phase 2 participants	Up to 5 weeks after last dose of treatment
Number of participants who achieve OR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based).	PTCL participants OR is defined as the achievement of PR or CR	Up to 4 years after last dose of treatment
Number of participants who achieve OR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based).	PTCL participants OR is defined as the achievement of PR or CR	Up to 4 years after last dose of treatment
Number of participants who achieve CR as assessed by central review per international consensus response criteria for ATL	ATL participants	Up to 4 years after last dose of treatment
Number of participants who achieve CR as assessed by investigator per international consensus response criteria for ATL	ATL participants	Up to 4 years after last dose of treatment
Time to response (TTR) as assessed by central review per international consensus response criteria for ATL	ATL participants	Up to 4 years after last dose of treatment
TTR as assessed by investigator per international consensus response criteria for ATL	ATL participants	Up to 4 years after last dose of treatment
Duration of response (DOR) as assessed by central review per international consensus response criteria for ATL	ATL Participants	Up to 4 years after last dose of treatment
DOR as assessed by investigator per international consensus response criteria for ATL	ATL Participants	Up to 4 years after last dose of treatment
Progression Free Survival (PFS) as assessed by central review per international consensus response criteria for ATL	ATL participants	Up to 4 years after last dose of treatment
PFS as assessed by investigator per international consensus response criteria for ATL	ATL participants	Up to 4 years after last dose of treatment
Number of participants who achieve disease control as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)	PTCL participants Disease control is considered to be SD, PR or CR	Up to 4 years after last dose of treatment
Number of participants who achieve disease control as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)	PTCL participants Disease control is considered to be SD, PR or CR	Up to 4 years after last dose of treatment
Number of participants who achieve CR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)	PTCL participants	Up to 4 years after last dose of treatment
Number of participants who achieve CR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)	PTCL participants	Up to 4 years after last dose of treatment
TTR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)	PTCL participants	Up to 4 years after last dose of treatment
TTR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)	PTCL participants	Up to 4 years after last dose of treatment
DOR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)	PTCL participants	Up to 4 years after last dose of treatment
DOR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)	PTCL participants	Up to 4 years after last dose of treatment
PFS as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)	PTCL participants	Up to 4 years after last dose of treatment
PFS as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)	PTCL participants	Up to 4 years after last dose of treatment
Number of participants who achieve OR as assessed by central review per international consensus response criteria for ATL	ATL participants OR is defined as the achievement of PR, CRu, or CR	Up to 4 years after last dose of treatment
Number of participants who achieve OR as assessed by investigator per international consensus response criteria for ATL	ATL participants OR is defined as the achievement of PR, CRu, or CR	Up to 4 years after last dose of treatment
Number of participants who achieve disease control as assessed by central review per international consensus response criteria for ATL	ATL participants Disease control is considered to be stable disease (SD), PR, CRu, or CR	Up to 4 years after last dose of treatment
Number of participants who achieve disease control as assessed by investigator per international consensus response criteria for ATL	ATL participants Disease control is considered to be SD, PR, CRu, or CR	Up to 4 years after last dose of treatment
Time to next treatment (TTNT)		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.
Overall survival (OS)		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.

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): October 10, 2030

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: CC-99282; BMS-986369; Golcadomide; Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL); Relapsed or Refractory Adult T-cell Leukemia/Lymphoma (R/R ATL); Adult T-cell leukemia/lymphoma (ATL); Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS); Angioimmunoblastic T-cell lymphoma and other nodal lymphomas of T follicular helper (TFH) cell origin; Angioimmunoblastic T-cell lymphoma (AITL); Follicular T-cell lymphoma (FTCL); Nodal peripheral T-cell lymphoma with TFH phenotype; Anaplastic large cell lymphoma, ALK-positive (ALCL, ALK+); Anaplastic large cell lymphoma, ALK-negative (ALCL, ALK-); Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL); Extranodal NK/T-cell lymphoma, nasal type (ENKL); Mycosis fungoides (MF)
• Additional Relevant MeSH Terms: Lymphadenopathy; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia; Leukemia, T-Cell; Lymphoma, T-Cell, Cutaneous; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large-Cell, Anaplastic; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Leukemia-Lymphoma, Adult T-Cell; Mycosis Fungoides; Lymphoma, Extranodal NK-T-Cell; Immunoblastic Lymphadenopathy
• Other Study ID Numbers: CA073-1008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes