Back to resultsA Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 in Participants With Relapsed or Refractory T-cell Lymphomas in Japan
Primary Purpose
Relapsed or Refractory T-cell Lymphomas
Status
Not yet recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
BMS-986369
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory T-cell Lymphomas focused on measuring Relapsed or Refractory Peripheral T-cell Lymphoma, Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
Eligibility Criteria
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
Sites / Locations
- Local Institution - 0001
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Administration of BMS-986369
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with Adverse Events (AEs)
Phase 1 participants
Number of participants with treatment-emergent adverse events (TEAEs)
Phase 1 participants
Number of participants with Dose-Limiting Toxicity (DLT)
Phase 1 participants
Number of participants with laboratory abnormalities
Phase 1 participants
Number of participants with vital sign abnormalities
Phase 1 participants
Number of participants with Electrocardiogram (ECG) abnormalities
Phase 1 participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Phase 1 participants
Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities
Phase 1 participants
Number of participants with Physical Examination (PE) abnormalities
Phase 1 participants
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)
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
Secondary Outcome Measures
Maximum observed plasma concentration (Cmax)
Area under the plasma concentration time-curve (AUC)
Time to peak (maximum) plasma concentration (Tmax)
Number of participants with AEs
Phase 2 participants
Number of participants with TEAEs
Phase 2 participants
Number of participants with laboratory abnormalities
Phase 2 participants
Number of participants with vital sign abnormalities
Phase 2 participants
Number of participants with ECG abnormalities
Phase 2 participants
ECOG PS
Phase 2 participants
Number of participants with LVEF assessment abnormalities
Phase 2 participants
Number of participants with PE abnormalities
Phase 2 participants
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
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
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
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
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
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
Number of participants who achieve CR as assessed by central review per international consensus response criteria for ATL
ATL participants
Number of participants who achieve CR as assessed by investigator per international consensus response criteria for ATL
ATL participants
Time to response (TTR) as assessed by central review per international consensus response criteria for ATL
ATL participants
TTR as assessed by investigator per international consensus response criteria for ATL
ATL participants
Duration of response (DOR) as assessed by central review per international consensus response criteria for ATL
ATL Participants
DOR as assessed by investigator per international consensus response criteria for ATL
ATL Participants
Progression Free Survival (PFS) as assessed by central review per international consensus response criteria for ATL
ATL participants
PFS as assessed by investigator per international consensus response criteria for ATL
ATL participants
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
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
Number of participants who achieve CR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
PTCL participants
Number of participants who achieve CR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
PTCL participants
TTR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
PTCL participants
TTR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
PTCL participants
DOR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
PTCL participants
DOR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
PTCL participants
PFS as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
PTCL participants
PFS as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
PTCL participants
Time to next treatment (TTNT)
Overall survival (OS)
Full Information
NCT ID
NCT06035497
First Posted
August 28, 2023
Last Updated
September 12, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT06035497
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
August 1, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory T-cell Lymphomas
Keywords
Relapsed or Refractory Peripheral T-cell Lymphoma, Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Administration of BMS-986369
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986369
Other Intervention Name(s)
Golcadomide, CC-99282
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events (AEs)
Description
Phase 1 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with treatment-emergent adverse events (TEAEs)
Description
Phase 1 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with Dose-Limiting Toxicity (DLT)
Description
Phase 1 participants
Time Frame
Up to 28 days after first dose
Title
Number of participants with laboratory abnormalities
Description
Phase 1 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with vital sign abnormalities
Description
Phase 1 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with Electrocardiogram (ECG) abnormalities
Description
Phase 1 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Description
Phase 1 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities
Description
Phase 1 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with Physical Examination (PE) abnormalities
Description
Phase 1 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL
Description
Phase 2: Adult T-cell Leukemia-Lymphoma (ATL) cohort
OR is defined as the achievement of Partial Response (PR) or Complete Response (CR)
Time Frame
Up to 2 years after last does of treatment
Title
Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based)
Description
Phase 2: Peripheral T-cell Lymphoma (PTCL) cohort
OR is defined as the achievement of PR or CR
Time Frame
Up to 2 years after last dose of treatment
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to Day 8 of Cycle 2 (each cycle is 28 days)
Title
Area under the plasma concentration time-curve (AUC)
Time Frame
Up to Day 8 of Cycle 2 (each cycle is 28 days)
Title
Time to peak (maximum) plasma concentration (Tmax)
Time Frame
Up to Day 8 of Cycle 2 (each cycle is 28 days)
Title
Number of participants with AEs
Description
Phase 2 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with TEAEs
Description
Phase 2 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with laboratory abnormalities
Description
Phase 2 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with vital sign abnormalities
Description
Phase 2 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with ECG abnormalities
Description
Phase 2 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
ECOG PS
Description
Phase 2 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with LVEF assessment abnormalities
Description
Phase 2 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants with PE abnormalities
Description
Phase 2 participants
Time Frame
Up to 5 weeks after last dose of treatment
Title
Number of participants who achieve OR as assessed by central review per international consensus response criteria for ATL
Description
ATL participants
OR is defined as the achievement of PR or CR
Time Frame
Up to 4 years after last dose of treatment
Title
Number of participants who achieve OR as assessed by investigator per international consensus response criteria for ATL
Description
ATL participants
OR is defined as the achievement of PR or CR
Time Frame
Up to 4 years after last dose of treatment
Title
Number of participants who achieve OR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based).
Description
PTCL participants
OR is defined as the achievement of PR or CR
Time Frame
Up to 4 years after last dose of treatment
Title
Number of participants who achieve OR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based).
Description
PTCL participants
OR is defined as the achievement of PR or CR
Time Frame
Up to 4 years after last dose of treatment
Title
Number of participants who achieve disease control as assessed by central review per international consensus response criteria for ATL
Description
ATL participants
Disease control is considered to be stable disease (SD), PR or CR
Time Frame
Up to 4 years after last dose of treatment
Title
Number of participants who achieve disease control as assessed by investigator per international consensus response criteria for ATL
Description
ATL participants
Disease control is considered to be SD, PR or CR
Time Frame
Up to 4 years after last dose of treatment
Title
Number of participants who achieve CR as assessed by central review per international consensus response criteria for ATL
Description
ATL participants
Time Frame
Up to 4 years after last dose of treatment
Title
Number of participants who achieve CR as assessed by investigator per international consensus response criteria for ATL
Description
ATL participants
Time Frame
Up to 4 years after last dose of treatment
Title
Time to response (TTR) as assessed by central review per international consensus response criteria for ATL
Description
ATL participants
Time Frame
Up to 4 years after last dose of treatment
Title
TTR as assessed by investigator per international consensus response criteria for ATL
Description
ATL participants
Time Frame
Up to 4 years after last dose of treatment
Title
Duration of response (DOR) as assessed by central review per international consensus response criteria for ATL
Description
ATL Participants
Time Frame
Up to 4 years after last dose of treatment
Title
DOR as assessed by investigator per international consensus response criteria for ATL
Description
ATL Participants
Time Frame
Up to 4 years after last dose of treatment
Title
Progression Free Survival (PFS) as assessed by central review per international consensus response criteria for ATL
Description
ATL participants
Time Frame
Up to 4 years after last dose of treatment
Title
PFS as assessed by investigator per international consensus response criteria for ATL
Description
ATL participants
Time Frame
Up to 4 years after last dose of treatment
Title
Number of participants who achieve disease control as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
Description
PTCL participants
Disease control is considered to be SD, PR or CR
Time Frame
Up to 4 years after last dose of treatment
Title
Number of participants who achieve disease control as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
Description
PTCL participants
Disease control is considered to be SD, PR or CR
Time Frame
Up to 4 years after last dose of treatment
Title
Number of participants who achieve CR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
Description
PTCL participants
Time Frame
Up to 4 years after last dose of treatment
Title
Number of participants who achieve CR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
Description
PTCL participants
Time Frame
Up to 4 years after last dose of treatment
Title
TTR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
Description
PTCL participants
Time Frame
Up to 4 years after last dose of treatment
Title
TTR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
Description
PTCL participants
Time Frame
Up to 4 years after last dose of treatment
Title
DOR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
Description
PTCL participants
Time Frame
Up to 4 years after last dose of treatment
Title
DOR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
Description
PTCL participants
Time Frame
Up to 4 years after last dose of treatment
Title
PFS as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
Description
PTCL participants
Time Frame
Up to 4 years after last dose of treatment
Title
PFS as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
Description
PTCL participants
Time Frame
Up to 4 years after last dose of treatment
Title
Time to next treatment (TTNT)
Time Frame
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.
Title
Overall survival (OS)
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site#
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bistol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0001
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
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
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