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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
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

NCT07335562

Not Yet RecruitingPhase 3

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Conditions: Systemic Sclerosis

Interventions: BMS-986353, Fludarabine, Cyclophosphamide, Tocilizumab, Rituximab

Countries: United States, Belgium, Canada, France, Germany, Italy, Japan, Spain

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

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 and/or anti-Topoisomerase I (anti-Scl-70) antibodies.

ii) 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:.

A. Arthritis.

B. Myositis.

C. Carditis.

D. Progressive skin disease.

E. 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.

Exclusion Criteria

* 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.
* Participants must not have moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment
* 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.
* 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.
Locations (56)
  • Scottsdale, Arizona, United States
  • Aurora, Colorado, United States
  • Denver, Colorado, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Worcester, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Rochester, Minnesota, United States
  • Summit, New Jersey, United States
  • Cleveland, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States
  • Leuven, Vlaams-Brabant, Belgium
  • Liège, Belgium
  • Halifax, Nova Scotia, Canada
  • Sherbrooke, Quebec, Canada
  • Strasbourg, Alsace, France
  • Toulouse, Haute-Garonne, France
  • Bordeaux, France
  • Bron, France
  • Paris, France
  • Rennes, France
  • Berlin, Germany
  • Cologne, Germany
  • Erlangen, Germany
  • + 26 more on CT.gov