A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 in Participants With Relapsed or Refractory T-cell Lymphomas in Japan

Study Overview
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Brief Summary
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The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of BMS-986369 in participants with relapsed or refractory T-cell lymphomas in Japan.

Official Title
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A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of BMS-986369 in Participants With Relapsed or Refractory T-cell Lymphomas in Japan

Conditions
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Relapsed or Refractory T-cell Lymphomas

Intervention / Treatment
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* Drug: BMS-986369


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have T-cell Lymphoma with relapsed or refractory disease, as assessed by the investigator 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. Note: Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of BMS-986369<br> | Drug: BMS-986369<br>* Specified dose on specified days<br>* Other names: CC-99282;|

What is the study measuring?
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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 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) 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 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 international consensus response criteria for ATL | ATL 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 international consensus response criteria for ATL | ATL 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 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 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 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 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 | 
| 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 4 years. | 
| 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 4 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsed or Refractory Peripheral T-cell Lymphoma, Relapsed or Refractory Adult T-cell Leukemia/Lymphoma