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BMS-986515

Phase 1

Refractory Autoimmune Diseases | Gene therapy | Immunology |Bristol-Myers Squibb Company|Last Updated: May 27, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment125
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07115745A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune DiseasesPHASE1 RECRUITING 125 — — Sep 4, 2025Aug 16, 2030May 27, 202628 United States, Australia +8
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Study Endpoints
Primary Endpoints
Number of participants with treatment-emergent adverse events (TEAEs)
Up to 24 months post BMS-986515 infusion

All participants

Number of participants with serious AEs (SAEs)
Up to 24 months post BMS-986515 infusion

All participants

Number of participants with AEs of special interest (AESIs)
Up to 24 months post BMS-986515 infusion

All participants

Number of participants with laboratory abnormalities
Up to 24 months post BMS-986515 infusion

All participants

Number of participants with Dose-Limiting Toxicities (DLTs)
Up to 24 months post BMS-986515 infusion

All participants

Number of participants with DLTs that occur during the DLT evaluation period
28 days post-BMS-986515 infusion

All participants

Secondary Endpoints
Maximum observed concentration (Cmax)
Up to 2 years
Area under the concentration-time curve (AUC)
Up to 2 years
Time of maximum observed concentration (Tmax)
Up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-986515 AdministrationEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986515GENETICSpecified dose on specified days
FludarabineDRUGSpecified dose on specified days
CyclophosphamideDRUGSpecified dose on specified days
TocilizumabDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria \- Systemic lupus erythematosus (SLE) population:. i) Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR). ii) Participant must be positive for at least one of the following antibodies at screening: anti-nuclear a...

Countries:United StatesAustraliaBrazilCzechiaFranceGermanyIsraelPolandRomaniaSpain
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Recent Changes (Last 90 Days)
LOWMay 28, 2026NCT07115745lastUpdatePostDate: changed
LOWMay 28, 2026NCT07115745lastUpdatePostDate: changed
LOWMay 26, 2026NCT07115745primaryCompletionDate: changed
LOWMay 24, 2026NCT07115745studyFirstPostDate: changed