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BMS-986458

Phase 1

Relapsed/Refractory Non-Hodgkin Lymphoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment308
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06090539A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin LymphomasPHASE1 RECRUITING 308 — — Dec 29, 2023Oct 28, 2028Apr 14, 202665 United States, Chile +11
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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 discontiunation
Up to 2 years and 1 month
Number of participants with AEs leading to death
Up to 2 years and 1 month
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A1EXPERIMENTALSingle Agent
Part A2EXPERIMENTALCombination Treatment
Part B1EXPERIMENTALSingle Agent
Part B2EXPERIMENTALCombination Treatment
Interventions
NameTypeDescription
BMS-986458DRUGSpecified dose on specified days.
RituximabDRUGSpecified dose on specified days.
Glofitamab/ObinutuzumabDRUGSpecified dose on specified days
MosunetuzumabDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites65

Inclusion Criteria: * Participants ≥ 18 years of age with R/R NHL (including DLBCL \[ie, DLBCL not otherwise specified (NOS) and diffuse large B-Cell lymphoma/high-grade B-Cell lymphoma with MYC and BCL2 rearrangements\], and FL): * For R/R DLBCL (de novo) and FL 3b: following at least 2 prior l...

Countries:United StatesChileChinaFranceGermanyGreeceItalyJapanNetherlandsSouth KoreaSpainSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06090539primaryCompletionDate: changed
LOWMay 24, 2026NCT06090539studyFirstPostDate: changed