Taking people in United StatesPhase 2/3
Tests CABA-201 cell therapy in people with systemic sclerosis
Tests CABA-201, a modified immune cell therapy, in adults with systemic sclerosis.
Key facts
- Who runs it
- Cabaletta Bio
- Where
- Ann Arbor, Chicago, Durham, Jacksonville, Kansas City, New Haven, New York, and Rochester, United StatesSee the 10 sites
- Trial code
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 37 people, planned
- Started
- 2 Jul 2024
- Expected to end
- Jul 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- CABA-201
- Record updated
- 16 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with early active systemic sclerosis and clear skin, lung or heart involvement. It tests a CAR T cell therapy called CABA-201.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Systemic sclerosis (scleroderma) in an early active stage, with significant skin, lung or heart involvement. Diagnosis follows the 2013 ACR/EULAR criteria.
- Earlier treatment
- People who had CAR T cell therapy before cannot join.
Main reasons for not taking part
- Cannot have leukapheresis (a procedure to collect blood cells)
- Severe reaction in the past to fludarabine or cyclophosphamide
- Active infection that needs treatment at screening
- Severe lung or heart impairment
- Earlier solid organ transplant (heart, liver, kidney, lung) or hematopoietic cell transplant
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in United States
- University of MichiganAnn Arbor, United StatesContact: Lynne BischoffTaking people
- Northwestern Memorial HospitalChicago, United StatesContact: Kaitlin KingTaking people
- The University of Chicago Medical CenterChicago, United StatesContact: Dequana JonesTaking people
- Duke UniversityDurham, United StatesContact: Khalia StewartTaking people
- Mayo Clinic FloridaJacksonville, United StatesContact: Gabrielle PariseauTaking people
- University of Kansas Medical CenterKansas City, United StatesContact: Theresa HowardTaking people
- Yale UniversityNew Haven, United StatesContact: Diane DocumetTaking people
- Columbia University Irving Medical CenterNew York, United StatesContact: Gaby YcazaTaking people
- Mayo Clinic - RochesterRochester, United StatesContact: Christi SagenTaking people
- University of RochesterRochester, United StatesContact: Chelsey LoMonacoTaking people
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- CABA-201 Phase 1/2Treatment being tested
Severe Skin Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with severe skin involvement Organ Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with organ involvement
Treatment: CABA-201
- CABA-201 Phase 2b - Sub-studyTreatment being tested
Infusion of CABA-201 with preconditioning in subjects with SSc
Treatment: CABA-201
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests CABA-201 cell therapy in people with systemic sclerosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06328777, who can take part
- Record updated
- 16 October 2026