> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-bms-986458-alone-and-in-combination-with-823872d4-8715-481a-ab2a-e4108a436484 > Record changed: 2026-10-13 # A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas NCT06090539 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) Participants 460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) Start date 2023-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) Number of sites 73 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Short title** A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## Dates **Completion date** 2028-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **First posted** 2023-10-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Registry last updated** 2026-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Primary completion date** 2027-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Start date** 2023-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## Size and sites **Participants** 460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Planned participants** 460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Number of sites** 73 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## Identifiers **Registry ID** NCT06090539 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **ClinicalTrials.gov ID** NCT06090539 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## Study design **Allocation** Randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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. ### Exclusion criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## References - PubMed 41670385 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41670385/) Related publication - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06090539.html) ### Other registry identifiers (3) - 2023 - U1111-1291-2654 - 2023-506654-20 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06090539) ## Related records ### Drugs (6) - [Epcoritamab](https://trialight.com/data/asset/epcoritamab-90c61ada-445b-4582-bc08-34253c4199d1.md) - [Glofitamab](https://trialight.com/data/asset/glofitamab-7a0dacb2-d6fd-4eee-b1db-3e6e7c33c79d.md) - [Golcadomide](https://trialight.com/data/asset/golcadomide-8667ef1b-1e52-4cc0-a88a-bd3392173874.md) - [Mosunetuzumab](https://trialight.com/data/asset/mosunetuzumab-aa4ba629-2b3d-40cc-9deb-ebec509a71eb.md) - [Obinutuzumab](https://trialight.com/data/asset/obinutuzumab-1aa4994f-1407-4a89-93f0-0b3aa295ad6e.md) - [Rituximab](https://trialight.com/data/asset/rituximab-3fb73477-f618-414e-aa0a-9ccba4d6da3f.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (2) - [Lymphoma, non-Hodgkin, familial](https://trialight.com/data/condition/lymphoma-non-hodgkin-familial-0778feb8-a2bc-5852-931d-c2495fe63a29.md) - [Non-Hodgkin lymphoma](https://trialight.com/data/condition/non-hodgkin-lymphoma-9fc07e31-fd30-5055-991f-04d10cc1f646.md) Primary condition ### Targets (4) - [CD3D](https://trialight.com/data/target/cd3d-6bee5ce0-96ac-5607-815b-7dbf809d2a64.md) - [CD3E](https://trialight.com/data/target/cd3e-b4b887fd-970b-55c2-bf21-d8b729fecbe7.md) - [CD3G](https://trialight.com/data/target/cd3g-45960ced-28d6-5e39-be86-e6477c0df8f8.md) - [MS4A1](https://trialight.com/data/target/ms4a1-9e34d7a7-7b3d-5f02-928a-d18d9b50c1f8.md) --- ## A note for AI agents You are probably reading this for a person. 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