AzTrials
AzTrials

Relapsed or Refractory T-cell LymphomasPhase 1/2NCT06035497

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 testing BMS-986369 in people with Relapsed or Refractory T-cell Lymphomas, run by Bristol-Myers Squibb at 40 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed or Refractory T-cell Lymphomas
What is being tested?
BMS-986369
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
40 sitesJapan
Study dates
20 Nov 2023to 10 Oct 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have one of the following subtypes of T-cell Lymphoma (TCL) with relapsed or refractory disease, as assessed by the investigator:.
  • Adult T-cell leukemia-lymphoma (ATL).
  • Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).
  • Angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of T follicular helper phenotype (TFH) cell origin.
  • Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase-positive (ALK+).
  • ALCL, anaplastic lymphoma kinase-negative (ALK-).
Show all 12Show fewer
  • Breast implant-associated ALCL.
  • Extranodal NK/T-cell lymphoma, nasal type (ENKL).
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

Japan40 sites

  • Local Institution - 0032

    Amagasaki, Hyōgo, 660-8550

  • Local Institution - 0031

    Anjo-shi, Aichi-ken, 446-8602

  • Local Institution - 0003

    Chuo-ku, Tokyo, 104-0045

  • Local Institution - 0018

    Fukuoka, 810-8563

  • Local Institution - 0012

    Fukuoka, 812-8582

  • Local Institution - 0023

    Fukuoka, 814-0180

  • Local Institution - 0009

    Hidaka, Saitama, 350-1298

  • Local Institution - 0039

    Hiroshima, 730-0052

  • Local Institution - 0025

    Hiroshima, 7348551

  • Local Institution - 0016

    Iizuka, Fukuoka, 820-8505

  • Local Institution - 0004

    Isehara, Kanagawa, 259-1193

  • Local Institution - 0029

    Itabashiku, Tokyo, 173-8610

  • Local Institution - 0015

    Kagoshima, 890-0064

  • Local Institution - 0008

    Kagoshima, 890-8520

  • Local Institution - 0017

    Kamogawa, Chiba, 296-0041

  • Local Institution - 0002

    Kashiwa, Chiba, 277-8577

  • Local Institution - 0041

    Kitakyushu-shi, Fukuoka, 806-8501

  • Local Institution - 0033

    Kobe, Hyōgo, 650-0047

  • Local Institution - 0040

    Koto, Tokyo, 135-8550

  • Local Institution - 0035

    Kumamoto, 860-0008

  • Local Institution - 0006

    Kumamoto, 860-8556

  • Local Institution - 0027

    Kyoto, 602-8566

  • Local Institution - 0026

    Minato-ku, Tokyo, 105-8471

  • Local Institution - 0022

    Mitaka, 181-8611

  • Local Institution - 0038

    Miyazaki, 889-1692

  • Local Institution - 0030

    Nagasaki, 852-8104

  • Local Institution - 0011

    Nagoya, Aichi-ken, 467-8602

  • Local Institution - 0037

    Narita, Chiba, 286-8520

  • Local Institution - 0020

    Ōita, 870-8511

  • Local Institution - 0007

    Okayama, 700-8558

  • Local Institution - 0042

    Okinawa, 904-2142

  • Local Institution - 0019

    Ōmura, Nagasaki, 8568562

  • Local Institution - 0010

    Osaka, 541-8567

  • Local Institution - 0034

    Osaka, 545-8586

  • Local Institution - 0005

    Ōsaka-sayama, Osaka, 589-8511

  • Local Institution - 0036

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0028

    Sasebo, Nagasaki, 857-8511

  • Local Institution - 0001

    Sendai, Miyagi, 980-8574

  • Local Institution - 0024

    Toyohashi, Aichi-ken, 441-8570

  • Local Institution - 0013

    Yokosuka, Kanagawa, 238-8558

Other trials in Japan

About this study

Official 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)

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).

Being tested
BMS-986369
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)
Medical subject headings
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986369Drug

    Also called Golcadomide, CC-99282

    Specified dose on specified days

Study groups in NCT06035497
Study groupRoleWhat they receive
Administration of BMS-986369ExperimentalNot described
Receives: Drug: BMS-986369

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Adverse Events (AEs)

    Phase 1 participants

    Measured: Up to 5 weeks after last dose of treatment

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

    Phase 1 participants

    Measured: Up to 5 weeks after last dose of treatment

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

    Phase 1 participants

    Measured: Up to 28 days after first dose

  4. Number of participants with laboratory abnormalities

    Phase 1 participants

    Measured: Up to 5 weeks after last dose of treatment

  5. Number of participants with vital sign abnormalities

    Phase 1 participants

    Measured: Up to 5 weeks after last dose of treatment

  6. Number of participants with Electrocardiogram (ECG) abnormalities

    Phase 1 participants

    Measured: Up to 5 weeks after last dose of treatment

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

    Phase 1 participants

    Measured: Up to 5 weeks after last dose of treatment

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

    Phase 1 participants

    Measured: Up to 5 weeks after last dose of treatment

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

    Phase 1 participants

    Measured: Up to 5 weeks after last dose of treatment

  10. 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)

    Measured: Up to 2 years after last does of treatment

  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)

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

    OR is defined as the achievement of PR or CR

    Measured: Up to 2 years after last dose of treatment

Secondary outcomes (37)

  1. Maximum observed plasma concentration (Cmax)

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

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

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

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

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

  4. Number of participants with AEs

    Phase 2 participants

    Measured: Up to 5 weeks after last dose of treatment

  5. Number of participants with TEAEs

    Phase 2 participants

    Measured: Up to 5 weeks after last dose of treatment

  6. Number of participants with laboratory abnormalities

    Phase 2 participants

    Measured: Up to 5 weeks after last dose of treatment

  7. Number of participants with vital sign abnormalities

    Phase 2 participants

    Measured: Up to 5 weeks after last dose of treatment

  8. Number of participants with ECG abnormalities

    Phase 2 participants

    Measured: Up to 5 weeks after last dose of treatment

  9. ECOG PS

    Phase 2 participants

    Measured: Up to 5 weeks after last dose of treatment

  10. Number of participants with LVEF assessment abnormalities

    Phase 2 participants

    Measured: Up to 5 weeks after last dose of treatment

  11. Number of participants with PE abnormalities

    Phase 2 participants

    Measured: Up to 5 weeks after last dose of treatment

  12. 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

    Measured: Up to 4 years after last dose of treatment

  13. 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

    Measured: Up to 4 years after last dose of treatment

  14. 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

    Measured: Up to 4 years after last dose of treatment

  15. 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

    Measured: Up to 4 years after last dose of treatment

  16. 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

    Measured: Up to 4 years after last dose of treatment

  17. 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

    Measured: Up to 4 years after last dose of treatment

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

    ATL participants

    Measured: Up to 4 years after last dose of treatment

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

    ATL participants

    Measured: Up to 4 years after last dose of treatment

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

    ATL participants

    Measured: Up to 4 years after last dose of treatment

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

    ATL participants

    Measured: Up to 4 years after last dose of treatment

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

    ATL Participants

    Measured: Up to 4 years after last dose of treatment

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

    ATL Participants

    Measured: Up to 4 years after last dose of treatment

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

    ATL participants

    Measured: Up to 4 years after last dose of treatment

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

    ATL participants

    Measured: Up to 4 years after last dose of treatment

  26. 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

    Measured: Up to 4 years after last dose of treatment

  27. 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

    Measured: Up to 4 years after last dose of treatment

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

    PTCL participants

    Measured: Up to 4 years after last dose of treatment

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

    PTCL participants

    Measured: Up to 4 years after last dose of treatment

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

    PTCL participants

    Measured: Up to 4 years after last dose of treatment

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

    PTCL participants

    Measured: Up to 4 years after last dose of treatment

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

    PTCL participants

    Measured: Up to 4 years after last dose of treatment

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

    PTCL participants

    Measured: Up to 4 years after last dose of treatment

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

    PTCL participants

    Measured: Up to 4 years after last dose of treatment

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

    PTCL participants

    Measured: Up to 4 years after last dose of treatment

  36. Time to next treatment (TTNT)

    Measured: 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)

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start20 Nov 2023
  3. Primary completion11 Aug 2026
  4. Study completion10 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06035497
Sponsor's protocol ID
CA073-1008
Status last verified
Oct 2026
First submitted
28 Aug 2023
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMS-986369 in people with Relapsed or Refractory T-cell Lymphomas, run by Bristol-Myers Squibb at 40 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Adverse Events (AEs) (time frame: Up to 5 weeks after last dose of treatment). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06035497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in