Recent Updates
Recently added Catalysts

BMS-986458

Phase 1

Relapsed/Refractory Non-Hodgkin Lymphoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 18, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment460

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986458 · 1 trial · 1 indication

Phase 1 1
NCT06090539A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin LymphomasRelapsed/Refractory Non-Hodgkin Lymphoma
RECRUITING460 Analytics
PHASE1RECRUITING
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
Relapsed/Refractory Non-Hodgkin LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
Up to 2 years and 1 month
Number of participants with serious adverse events (SAEs)
Up to 2 years and 1 month
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Up to Day 28
Number of participants with AEs leading to death
Up to 2 years and 1 month
Number of participants with AEs leading to discontinuation
Up to 2 years and 1 month
Number of participants with a complete response rate (CRR) according to the Lugano response criteria for Non-Hodgkin Lymphoma by Investigator assessment
Up to 2 years and 11 month

Part B2 Cohort B only

Secondary Endpoints

Maximum concentration (Cmax)
Up to 4 months
Time of maximum concentration (Tmax)
Up to 4 months
Area under the plasma concentration-time curve within a dosing interval [AUC(TAU)]
Up to 4 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A1EXPERIMENTALSingle Agent
Part A2EXPERIMENTALCombination Treatment
Part B1EXPERIMENTALSingle Agent
Part B2EXPERIMENTALCombination Treatment
Part B3EXPERIMENTALSingle Agent

Interventions

NameTypeDescription
BMS-986458DRUGSpecified dose on specified days.
RituximabDRUGSpecified dose on specified days.
Glofitamab/ObinutuzumabDRUGSpecified dose on specified days
MosunetuzumabDRUGSpecified dose on specified days
EpcoritamabDRUGSpecified dose on specified days
GolcadomideDRUGSpecified dose on specified days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites73

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 resonanc...

Countries:United StatesChileChinaFranceGermanyGreeceHong KongItalyJapanNetherlandsSouth KoreaSpainSwitzerlandTurkey (Türkiye)United Kingdom
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWAug 19, 2026NCT06090539lastUpdatePostDate: changed
LOWAug 19, 2026NCT06090539lastUpdatePostDate: changed
LOWAug 19, 2026NCT06090539lastUpdatePostDate: changed
MEDIUMJun 22, 2026NCT06090539Enrollment: 308 → 460
MEDIUMJun 22, 2026NCT06090539Enrollment: 308 → 460

Frequently asked questions about BMS-986458

What is BMS-986458 used for?

BMS-986458 is an investigational small molecule being studied for the treatment of relapsed/refractory Non-Hodgkin Lymphoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes BMS-986458?

BMS-986458 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is BMS-986458 in?

BMS-986458 is in Phase 1 clinical development. It is an investigational drug being studied in a Phase 1 trial for relapsed/refractory Non-Hodgkin Lymphoma, and it has not yet received FDA approval.

What clinical trials is BMS-986458 in?

BMS-986458 is being studied in a Phase 1 clinical trial with the identifier NCT06090539. This trial evaluates BMS-986458 alone and in combination with anti-lymphoma agents in patients with relapsed/refractory Non-Hodgkin Lymphoma, with an enrollment of 460 participants.

How does BMS-986458 work?

BMS-986458 is a small molecule therapeutic being developed for oncology. As a small molecule, it is designed to interact with cellular targets to exert its effects, though the specific molecular target has not been disclosed in available information.