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BMS-986353

Phase 3

Systemic Sclerosis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Jun 15, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment92
FDA Designations
No designations recorded
Clinical trial landscape

BMS-986353 · 2 trials · 3 indications

Phase 3 1Phase 2 1
NCT07335562A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic SclerosisSystemic Sclerosis
RECRUITING92 Analytics
PHASE3RECRUITING
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
Systemic Sclerosis
NCT0733556292
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Study Endpoints
Primary Endpoints
The absolute change from baseline in Forced Vital Capacity (FVC) in mL
At 12 months
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
The absolute change from baseline in Modified Rodnan Skin Score (mRSS)
At month 12
The absolute change from baseline in Quantitative Interstitial Lung Disease-Whole Lung (QILD-WL) score
Up to month 36
Time to progression, defined as the time from randomization to progressive disease
Approximately 54 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A: BMS-986353EXPERIMENTAL -
Arm B: Standard of CareEXPERIMENTAL -
Cohort 1 Part A ITPEXPERIMENTAL -
Cohort 1 Part A AIHAEXPERIMENTAL -
Cohort 1 Part BEXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986353DRUGSpecified dose on specified days
FludarabineDRUGSpecified dose on specified days
CyclophosphamideDRUGSpecified dose on specified days
TocilizumabDRUGSpecified dose on specified days
RituximabDRUGSpecified dose on specified days
NintedanibDRUGSpecified dose on specified days
Fludarabine PhosphateDRUGSpecified dose of specified days
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Eligibility Criteria
Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites56

Inclusion Criteria \- Participants must fulfill the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:. i) Positive Antinuclear Antibodies (ANA) with nucleolar pattern a...

Countries:United StatesBelgiumCanadaFranceGermanyItalyJapanSpainSwitzerlandUnited KingdomDenmark
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Competitive Landscape -Systemic Sclerosis 30 trials

Top 20 of 21 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN2PHASE3Anifrolumab
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986353, Fludarabine, Cyclophosphamide, Tocilizumab, Rituximab
Merck & Co., Inc.MRK1PHASE2Tulisokibart
Novartis AG Sponsored ADRNVS2PHASE2rapcabtagene autoleucel, rituximab
GSK plc Sponsored ADRGSK1PHASE2Belimumab
argenx SE Sponsored ADRARGX1PHASE2Efgartigimod PH20
Cumberland Pharmaceuticals Inc.CPIX1PHASE2Ifetroban
Zura Bio Limited Class AZURA1PHASE2Tibulizumab
Artiva Biotherapeutics, Inc.ARTV1PHASE2Allogeneic NK Cells
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Kyverna Therapeutics, Inc.KYTX3PHASE1KYV-101, Standard lymphodepletion regimen
CRISPR Therapeutics AGCRSP1PHASE1CTX112
Allogene Therapeutics, Inc.ALLO1PHASE1ALLO-329, Cyclophosphamide, Fludarabine
Fate Therapeutics, Inc.FATE1PHASE1FT819, Fludarabine, Cyclophosphamide, Bendamustine
Nkarta, Inc.NKTX1PHASE1NKX019, Fludarabine, Cyclophosphamide
Adicet Bio IncACET1PHASE1ADI-001, Fludarabine, Cyclophosphamide
Cabaletta Bio, Inc.CABA1PHASE1CABA-201
Century Therapeutics, Inc.IPSC1PHASE1CNTY-101, IL-2, Lymphodepleting Chemotherapy
Precision BioSciences, Inc.DTIL2PHASE1BCMA/CD70-targetd CAR-T
TScan Therapeutics, Inc.TCRX1 - Undisclosed
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Recent Changes (Last 90 Days)
LOWJun 16, 2026NCT07335562startDate: changed
LOWJun 16, 2026NCT07335562startDate: changed
LOWJun 16, 2026NCT07335562startDate: changed
LOWJun 16, 2026NCT07335562startDate: changed
LOWMay 26, 2026NCT07335562Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07335562studyFirstPostDate: changed