A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas

NCT06090539
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
460
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Lead sponsor
Bristol-Myers Squibb
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Start date
2023-12-29
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Number of sites
73
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Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader of B-cell lymphoma 6 (BCL6), as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.
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Short title
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
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Official title
A Phase 1/2, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2028-10-28
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First posted
2023-10-19
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Registry last updated
2026-08-18
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Primary completion date
2027-10-28
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Start date
2023-12-29
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Participants
460
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Participant count basis
Estimated
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Planned participants
460
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Protocol amendments
3
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Number of sites
73
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Bristol-Myers Squibb
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06090539
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ClinicalTrials.gov ID
NCT06090539
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Registry record
Open registry record
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Allocation
Randomised
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of participants with adverse events (AEs)

    Timeframe: Up to 2 years and 1 month

  2. Number of participants with serious adverse events (SAEs)

    Timeframe: Up to 2 years and 1 month

  3. Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

    Timeframe: Up to Day 28

  4. Number of participants with AEs leading to death

    Timeframe: Up to 2 years and 1 month

  5. Number of participants with AEs leading to discontinuation

    Timeframe: Up to 2 years and 1 month

  6. Number of participants with a complete response rate (CRR) according to the Lugano response criteria for Non-Hodgkin Lymphoma by Investigator assessment

    Timeframe: Up to 2 years and 11 month

    Part B2 Cohort B only

  1. Maximum concentration (Cmax)

    Timeframe: Up to 4 months

  2. Time of maximum concentration (Tmax)

    Timeframe: Up to 4 months

  3. Area under the plasma concentration-time curve within a dosing interval [AUC(TAU)]

    Timeframe: Up to 4 months

  4. Number of participants with a complete response rate (CRR) according to the Lugano response criteria for Non-Hodgkin Lymphoma by Investigator assessment

    Timeframe: Up to 2 years

  5. Number of participants with an overall response rate (ORR) according to the Lugano response criteria for Non-Hodgkin Lymphoma by investigator assessment

    Timeframe: Up to 2 years

  6. Duration of response (DOR)

    Timeframe: Up to 3 years

  7. Time to response (TTR)

    Timeframe: Up to 3 years

  8. Progression-free survival (PFS)

    Timeframe: Up to 3 years

  9. Overall survival (OS)

    Timeframe: Up to 3 years

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Participants ≥ 18 years of age with frontline or R/R NHL.
  • Participant must have measurable disease (defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion > 1.5 cm in the transverse diameter).
  • Participants must accept and follow pregnancy prevention plan.

  • Participants must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
  • Participants with an inability to comply with listed restrictions, precautions and prohibited treatments.
  • Participants must not have prior CAR-T, or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months (only applicable to BMS-986458 single agent or rituximab combination cohorts), or autologous SCT ≤ 3 months prior to study intervention initiation.
  • In BMS-986458 + T-cell engager combination cohorts: Participants must not have prior alloSCT or solid organ transplantation, history of confirmed progressive multifocal leukoencephalopathy (PML); known or suspected history of hemophagocytic lymphohistiocytosis (HLH); known or suspected chronic active Epstein-Barr (EBV) infection.
  • Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
  • Participants must not have known or suspected central nervous system involvement.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Sources for eligibility
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  • Mayo Clinic in Arizona - PhoenixPhoenix, United StatesRecruiting
  • City of Hope Comprehensive Cancer CenterDuarte, United StatesRecruiting
  • Local Institution - 0068Jacksonville, United StatesNot yet recruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • Mayo Clinic in Rochester, MinnesotaRochester, United StatesRecruiting
  • Local Institution - 0124Omaha, United StatesNot yet recruiting
  • Local Institution - 0047Lake Success, United StatesCompleted
  • Local Institution - 0037New York, United StatesNot yet recruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Local Institution - 0045Providence, United StatesNot yet recruiting
  • Local Institution - 0118Antofagasta, ChileNot yet recruiting
  • Local Institution - 0105Santiago, ChileNot yet recruiting
  • Local Institution - 0109Santiago, ChileNot yet recruiting
  • Beijing Cancer hospitalBeijing, ChinaRecruiting
  • Local Institution - 0084Guangzhou, ChinaNot yet recruiting
  • Local Institution - 0087Zhengzhou, ChinaNot yet recruiting
  • The First Affiliated Hospital of Nanchang UniversityNanchang, ChinaRecruiting
  • Local Institution - 0130Nanchang, ChinaNot yet recruiting
  • Local Institution - 0131Shanghai, ChinaNot yet recruiting
  • Local Institution - 0128Hangzhou, ChinaNot yet recruiting
  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud OuestBordeaux, FranceRecruiting
  • Local Institution - 0125Lyon, FranceNot yet recruiting
  • Hopital Claude Huriez - CHU de LilleLille, FranceRecruiting
  • Gustave RoussyVillejuif, FranceRecruiting

And 48 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • U1111-1291-2654
  • 2023-506654-20
Sources for references
clinicaltrials.gov

Related records

Drugs (6)

Lead sponsors (1)

Conditions (2)

Targets (4)