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)

NCT06035497 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CA073-1008
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 40

Brief Summary

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).

Conditions

Relapsed or Refractory T-cell Lymphomas

Keywords

Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL); Relapsed or Refractory Adult T-cell Leukemia/Lymphoma (R/R ATL); Golcadomide; BMS-986369; CC-99282; 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)

Outcome Measures

Primary Outcomes (11)

• 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 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

• 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

Secondary Outcomes (37)

• 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

  Up to 5 weeks after last dose of treatment

• Number of participants with TEAEs

  Up to 5 weeks after last dose of treatment

Study Arms (1)

Administration of BMS-986369

EXPERIMENTAL

Drug: BMS-986369

Interventions

BMS-986369 DRUG

Specified dose on specified days

Also known as: Golcadomide, CC-99282

Administration of BMS-986369

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (40)

Local Institution - 0031

Anjo-shi, Aichi-ken, 446-8602, Japan

Location

Local Institution - 0011

Nagoya, Aichi-ken, 467-8602, Japan

Location

Local Institution - 0024

Toyohashi, Aichi-ken, 441-8570, Japan

Location

Local Institution - 0017

Kamogawa, Chiba, 296-0041, Japan

Location

Local Institution - 0002

Kashiwa, Chiba, 277-8577, Japan

Location

Local Institution - 0037

Narita, Chiba, 286-8520, Japan

Location

Local Institution - 0016

Iizuka, Fukuoka, 820-8505, Japan

Location

Local Institution - 0041

Kitakyushu-shi, Fukuoka, 806-8501, Japan

Location

Local Institution - 0036

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 0032

Amagasaki, Hyōgo, 660-8550, Japan

Location

Local Institution - 0033

Kobe, Hyōgo, 650-0047, Japan

Location

Local Institution - 0004

Isehara, Kanagawa, 259-1193, Japan

Location

Local Institution - 0013

Yokosuka, Kanagawa, 238-8558, Japan

Location

Local Institution - 0001

Sendai, Miyagi, 980-8574, Japan

Location

Local Institution - 0019

Ōmura, Nagasaki, 8568562, Japan

Location

Local Institution - 0028

Sasebo, Nagasaki, 857-8511, Japan

Location

Local Institution - 0005

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Local Institution - 0009

Hidaka, Saitama, 350-1298, Japan

Location

Local Institution - 0003

Chuo-ku, Tokyo, 104-0045, Japan

Location

Local Institution - 0029

Itabashiku, Tokyo, 173-8610, Japan

Location

Local Institution - 0040

Koto, Tokyo, 135-8550, Japan

Location

Local Institution - 0026

Minato-ku, Tokyo, 105-8471, Japan

Location

Local Institution - 0018

Fukuoka, 810-8563, Japan

Location

Local Institution - 0012

Fukuoka, 812-8582, Japan

Location

Local Institution - 0023

Fukuoka, 814-0180, Japan

Location

Local Institution - 0039

Hiroshima, 730-0052, Japan

Location

Local Institution - 0025

Hiroshima, 7348551, Japan

Location

Local Institution - 0015

Kagoshima, 890-0064, Japan

Location

Local Institution - 0008

Kagoshima, 890-8520, Japan

Location

Local Institution - 0035

Kumamoto, 860-0008, Japan

Location

Local Institution - 0006

Kumamoto, 860-8556, Japan

Location

Local Institution - 0027

Kyoto, 602-8566, Japan

Location

Local Institution - 0022

Mitaka, 181-8611, Japan

Location

Local Institution - 0038

Miyazaki, 889-1692, Japan

Location

Local Institution - 0030

Nagasaki, 852-8104, Japan

Location

Local Institution - 0007

Okayama, 700-8558, Japan

Location

Local Institution - 0042

Okinawa, 904-2142, Japan

Location

Local Institution - 0010

Osaka, 541-8567, Japan

Location

Local Institution - 0034

Osaka, 545-8586, Japan

Location

Local Institution - 0020

Ōita, 870-8511, Japan

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Recurrence; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Leukemia-Lymphoma, Adult T-Cell; Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Immunoblastic Lymphadenopathy; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Extranodal NK-T-Cell; Mycosis Fungoides

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphadenopathy; Lymphoma, T-Cell, Cutaneous

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 13, 2023
• Study Start: November 20, 2023
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): October 10, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

JP (40)