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BMS-986353

Phase 2

Chronic Immune Thrombocytopenia | Monoclonal antibody | Hematology |Bristol-Myers Squibb Company|Last Updated: May 22, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07603557Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)PHASE2 NOT YET_RECRUITING 52 — — Jun 15, 2026May 6, 2030May 22, 20268 United States, Denmark +2
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Study Endpoints
Primary Endpoints
Cohort 1 Part A: Number of participants with treatment-emergent adverse events (TEAEs)
Up to approximately Month 36
Cohort 1 Part A: Number of participants with serious AEs (SAEs)
Up to approximately Month 36
Cohort 1 Part A: Number of participants with AEs of special interest (AESI)
Up to approximately Month 36
Cohort 1 Part A: Number of participants with clinically significant laboratory abnormalities
Up to approximately Month 36
Cohort 1 Part B: Hematologic Complete Response (CR)
Up to approximately Month 6
Secondary Endpoints
Cohort 1 PART B: Hematologic Overall Response (OR)
Up to approximately Month 6
Cohort 1 PART A and Cohort 2: Hematologic CR and OR
Up to approximately Month 6
Cohort 1 PART B and Cohort 2: Number of participants with TEAEs
Up to approximately Month 36
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1 Part A ITPEXPERIMENTAL -
Cohort 1 Part A AIHAEXPERIMENTAL -
Cohort 1 Part BEXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986353BIOLOGICALSpecified dose of specified days
Fludarabine PhosphateDRUGSpecified dose of specified days
CyclophosphamideDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria Inclusion Criteria for ITP * Documented clinical diagnosis of chronic ITP (cITP) without other clinical manifestations of systemic autoimmune disease. * Has relapsed after or is intolerant to corticosteroids (with or without intravenous immunoglobulin (IVIG) or anti-Rh0(D) Ig) A...

Countries:United StatesDenmarkGermanyUnited Kingdom
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