Evaluating a new CAR T cell therapy for systemic sclerosis
A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Systemic Sclerosis
This study is testing a new CAR T cell therapy to see if it can help people with systemic sclerosis feel better and manage their symptoms.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cabaletta Bio Industry-sponsored |
| Drugs / interventions | CAR T, cyclophosphamide, fludarabine |
| Locations | 10 sites (New Haven, Connecticut and 9 other locations) |
| Trial ID | NCT06328777 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a clinical diagnosis of systemic sclerosis and evidence of significant organ involvement.
Not a fit: Patients with severe uncontrolled diseases or contraindications to the study medications may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients suffering from systemic sclerosis, potentially improving their quality of life.
How similar studies have performed: While CAR T cell therapies have shown promise in other autoimmune conditions, this specific application for systemic sclerosis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut and 9 other locations
- 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)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Cabaletta Bio
- Email: clinicaltrials@cabalettabio.com
- Phone: 267 759 3100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.