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Trial ID CA061-1005  |   NCT07335562

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

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 16+
    Age Range
  • 36
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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

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Key Eligibility Criteria

Inclusion Criteria

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  • 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:.
    1. Positive Antinuclear Antibodies (ANA) with nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies.
      1. Confirmation of Interstitial Lung Disease (ILD) on centrally read High-Resolution Computed Tomography (HRCT) with ≥ 10% total lung involvement, with at least one of the following attributed to active SSc:.
        1. Arthritis.
        2. Myositis.
        3. Carditis.
        4. Progressive skin disease.
        5. Elevated inflammatory markers.
    2. Participants must have a non-response or intolerance despite ≥ 6 months of treatment with at least one immunomodulatory drug. Non-response is defined as a patient, who in the opinion of the investigator, is not adequately controlled/treated and requires treatment escalation.

      Exclusion Criteria

      Exclusion Criteria Icon
      • Participants must not have a requirement for supplemental oxygen therapy and/or Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≤ 40% (Hemoglobin (Hgb) corrected) at screening.
        1. Participants must not have moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment
          1. Participants must not have pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral corticosteroids, cigarette smoking (including e-cigarettes) within 3 months before screening or unwilling to avoid smoking throughout the study, and/or clinically significant abnormalities on HRCT not attributable to SSc assessed by the central reader at screening.
            1. Participants must not have gastrointestinal (GI) dysmotility requiring Total Parenteral Nutrition (TPN).
              1. Participants must not have current gangrene of a digit
                Additional Information *
                • Other protocol-defined Inclusion/Exclusion criteria apply.

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Arm A: BMS-986353

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986353, Fludarabine, Cyclophosphamide

                  Study Arms

                  Experimental: Arm B: Standard of Care

                  ASSIGNED INTERVENTION
                  • Drug: Tocilizumab, Rituximab, Nintedanib
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