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

Korábbi kezelés

• 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.

Más betegség

• Participants must not have moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment

Laborértékek

• 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.

Egyéb

• Participants must not have gastrointestinal (GI) dysmotility requiring Total Parenteral Nutrition (TPN).
• Participants must not have current gangrene of a digit
• Other protocol-defined Inclusion/Exclusion criteria apply.

• 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:.
• Positive Antinuclear Antibodies (ANA) with nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies.
• 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:.
• Arthritis.
• Myositis.
• Carditis.
• Progressive skin disease.
• Elevated inflammatory markers.
• 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.