Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Japan / NCT06035497
Active, not recruiting Phase 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)

NCT06035497 · tracked via the Priya Life Science Japan tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 1/2
Started
2023-11-20
Last updated
2026-10-07

Condition(s) studied

Relapsed or Refractory T-cell Lymphomas

Investigational drug(s) / intervention(s)

BMS-986369 →

BMS-986369: Specified dose on specified days

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of participants with Adverse Events (AEs) — Up to 5 weeks after last dose of treatment
    Phase 1 participants
  • Number of participants with treatment-emergent adverse events (TEAEs) — Up to 5 weeks after last dose of treatment
    Phase 1 participants
  • Number of participants with Dose-Limiting Toxicity (DLT) — Up to 28 days after first dose
    Phase 1 participants
  • Number of participants with laboratory abnormalities — Up to 5 weeks after last dose of treatment
    Phase 1 participants
  • Number of participants with vital sign abnormalities — Up to 5 weeks after last dose of treatment
    Phase 1 participants
  • Number of participants with Electrocardiogram (ECG) abnormalities — Up to 5 weeks after last dose of treatment
    Phase 1 participants
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) — Up to 5 weeks after last dose of treatment
    Phase 1 participants
  • Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities — Up to 5 weeks after last dose of treatment
    Phase 1 participants
  • Number of participants with Physical Examination (PE) abnormalities — Up to 5 weeks after last dose of treatment
    Phase 1 participants
  • Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL — 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)
  • Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based) — 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

Trial sites (40)

FacilityCityRegionStatus
Local Institution - 0031 Anjo-shi Aichi-ken
Local Institution - 0011 Nagoya Aichi-ken
Local Institution - 0024 Toyohashi Aichi-ken
Local Institution - 0017 Kamogawa Chiba
Local Institution - 0002 Kashiwa Chiba
Local Institution - 0037 Narita Chiba
Local Institution - 0016 Iizuka Fukuoka
Local Institution - 0041 Kitakyushu-shi Fukuoka
Local Institution - 0036 Sapporo Hokkaido
Local Institution - 0032 Amagasaki Hyōgo
Local Institution - 0033 Kobe Hyōgo
Local Institution - 0004 Isehara Kanagawa
Local Institution - 0013 Yokosuka Kanagawa
Local Institution - 0001 Sendai Miyagi
Local Institution - 0019 Ōmura Nagasaki
Local Institution - 0028 Sasebo Nagasaki
Local Institution - 0005 Ōsaka-sayama Osaka
Local Institution - 0009 Hidaka Saitama
Local Institution - 0003 Chuo-ku Tokyo
Local Institution - 0029 Itabashiku Tokyo
Local Institution - 0040 Koto Tokyo
Local Institution - 0026 Minato-ku Tokyo
Local Institution - 0018 Fukuoka Japan
Local Institution - 0012 Fukuoka Japan
Local Institution - 0023 Fukuoka Japan
Local Institution - 0039 Hiroshima Japan
Local Institution - 0025 Hiroshima Japan
Local Institution - 0015 Kagoshima Japan
Local Institution - 0008 Kagoshima Japan
Local Institution - 0035 Kumamoto Japan
Local Institution - 0006 Kumamoto Japan
Local Institution - 0027 Kyoto Japan
Local Institution - 0022 Mitaka Japan
Local Institution - 0038 Miyazaki Japan
Local Institution - 0030 Nagasaki Japan
Local Institution - 0007 Okayama Japan
Local Institution - 0042 Okinawa Japan
Local Institution - 0010 Osaka Japan
Local Institution - 0034 Osaka Japan
Local Institution - 0020 Ōita Japan

More Bristol-Myers Squibb trials in Japan

A Study of Navlimetostat (BMS-986504) Alone or in Combination With Izalontamab Brengitecan in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion or MTAP Loss (MountainTAP-9) Recruiting
A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS). Recruiting
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors Recruiting
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission Active, not recruiting
A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06035497 on ClinicalTrials.gov ↗ ← All trials in Japan