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
Key facts
- Where
- Ann Arbor, Chicago, Durham, Jacksonville, Kansas City, New Haven, New York és Rochester, Egyesült ÁllamokSee the 10 sites
- Phase
- 2/3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06328777, who can take part
Where in Egyesült Államok
- University of MichiganAnn Arbor, Egyesült ÁllamokTaking people
- Northwestern Memorial HospitalChicago, Egyesült ÁllamokTaking people
- The University of Chicago Medical CenterChicago, Egyesült ÁllamokTaking people
- Duke UniversityDurham, Egyesült ÁllamokTaking people
- Mayo Clinic FloridaJacksonville, Egyesült ÁllamokTaking people
- University of Kansas Medical CenterKansas City, Egyesült ÁllamokTaking people
- Yale UniversityNew Haven, Egyesült ÁllamokTaking people
- Columbia University Irving Medical CenterNew York, Egyesült ÁllamokTaking people
- Mayo Clinic - RochesterRochester, Egyesült ÁllamokTaking people
- University of RochesterRochester, Egyesült ÁllamokTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cabaletta Bio
- Trial code
- NCT06328777
- Record updated
- 2026. október 16.
- Original description
RESET-SSc: A 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 SclerosisRead full original descriptionShow less
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
RESET-SSc: A 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
Inclusion: 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: 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; 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; 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; Severe lung or cardiac impairment; Contraindication to leukapheresis.