Evaluating a new CAR T cell therapy for systemic sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of CABA-201, a CD19-CAR T cell therapy, in patients with systemic sclerosis (SSc), a rare autoimmune disorder. Participants aged 18 to 75 with early active disease and significant organ involvement will receive a single dose of CABA-201 alongside cyclophosphamide and fludarabine. The study aims to assess how well this therapy can improve symptoms and manage the disease. It is an open-label study, meaning both the researchers and participants know the treatment being administered.

Why it matters

Who can join: the full rules

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, 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.

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting
• The University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Study coordinator: Cabaletta Bio
• Email: clinicaltrials@cabalettabio.com
• Phone: 267 759 3100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting at 17 sites Phase 1 Allogene Therapeutics · Phoenix, Arizona and 17 other locations · NCT07085104

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

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• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

  This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.