Cabaletta Bio Issued ID#NCT06328777 For Phase 1/2 Open-Label Study To Evaluate The Safety And Efficacy Of CABA-201, A CD19-CAR T Cell Therapy, In Subjects With Systemic Sclerosis Posted To Clinical Trials Website On 2024-03-25; Study Is Not Yet Recruiting

Author: Benzinga Newsdesk | March 25, 2024 10:25am

https://clinicaltrials.gov/study/NCT06328777

 

Inclusion Criteria:

• Age ≥18 and ≤70
• A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria.
• Early active disease
• Evidence of significant skin, pulmonary, renal, or cardiac involvement

Exclusion Criteria:

• Contraindication to leukapheresis
• History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites
• Active infection requiring medical intervention at screening visit
• Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
• Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
• Severe lung or cardiac impairment
• Previous CAR T cell therapy
• Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant

Other protocol-defined inclusion/exclusion criteria may apply.

Posted In: CABA