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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ID
NCT07335562
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986353 — DRUG
    Specified dose on specified days
  • Fludarabine — DRUG
    Specified dose on specified days
  • Cyclophosphamide — DRUG
    Specified dose on specified days
  • Tocilizumab — DRUG
    Specified dose on specified days
  • Rituximab — DRUG
    Specified dose on specified days
  • Nintedanib — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis

Key Dates

Start date
May 29, 2026
Status verified
May 2026
Primary completion
Nov 14, 2028
Completion
Nov 11, 2030

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: BMS-986353
  • Experimental: Arm B: Standard of Care

Primary Outcome Measure

The absolute change from baseline in Forced Vital Capacity (FVC) in mL [ Time Frame: At 12 months ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (16)

FacilityCityStateZIPSite coordinators
Local Institution - 0035ScottsdaleArizona85259
Site 0035
University of Colorado Anschutz Medical CampusAuroraColorado80045
Melissa Griffith, Site 0092
720-848-7700
Local Institution - 0001DenverColorado80218
Site 0001
Local Institution - 0069MiamiFlorida33136
Site 0069
Emory University School of MedicineAtlantaGeorgia30322
Arezou Khosroshahi, Site 0014
404-778-6638
Local Institution - 0139ChicagoIllinois60611
Site 0139
Local Institution - 0084WorcesterMassachusetts01655
Site 0084
Local Institution - 0034Ann ArborMichigan48109
Site 0034
Local Institution - 0037RochesterMinnesota55905
Site 0037
Local Institution - 0082SummitNew Jersey07901
Site 0082
Local Institution - 0122ClevelandOhio44195
Site 0122
Local Institution - 0142PhiladelphiaPennsylvania19104
Site 0142
Local Institution - 0143PittsburghPennsylvania15224
Site 0143
Local Institution - 0002CharlestonSouth Carolina29425
Site 0002
Local Institution - 0074DallasTexas75390
Site 0074
Local Institution - 0008SeattleWashington98109
Site 0008

Find similar trials in Scottsdale, AZ

By research site
Local Institution - 0035· Scottsdale, AZUniversity of Colorado Anschutz Medical Campus· Aurora, COLocal Institution - 0001· Denver, COLocal Institution - 0069· Miami, FLEmory University School of Medicine· Atlanta, GALocal Institution - 0139· Chicago, IL

Related Studies