RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis

Launched by CABALETTA BIO · Mar 19, 2024

Keywords

ClinConnect Summary

The RESET-SSc clinical trial is studying a new treatment called CABA-201, which is a type of therapy that modifies a patient’s own immune cells to help fight systemic sclerosis (also known as scleroderma). This trial is specifically looking at how safe and effective this therapy is for people who have early active disease with significant symptoms affecting their skin, lungs, kidneys, or heart.

To participate in the study, individuals must be between 18 and 70 years old and have a diagnosis of systemic sclerosis based on specific medical guidelines. However, some people may not be eligible if they have certain health issues, a history of severe allergic reactions to specific medications, or if they have had previous similar therapies. Participants in the trial will receive the treatment and be closely monitored by healthcare professionals to evaluate how well it works and to ensure their safety. Overall, this trial aims to explore a promising new option for managing systemic sclerosis symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 and ≤75
• • 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.