Actively Recruiting
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
Led by Cabaletta Bio · Updated on 2026-05-14
12
Participants Needed
10
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Clinical diagnosis of systemic sclerosis based on 2013 American College of Rheumatology and European League Against Rheumatism criteria
- Early active systemic sclerosis disease
- Significant skin, pulmonary, renal, or cardiac involvement
You will not qualify if you...
- Contraindication to leukapheresis
- History of severe allergic reaction to fludarabine, cyclophosphamide, or their metabolites
- Active infection requiring medical treatment at screening
- Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease
- Severe and uncontrolled infections such as sepsis or opportunistic infections
- Other medical conditions posing unacceptable risk or interfering with study procedures
- Severe lung or cardiac impairment
- Previous CAR T cell therapy
- Prior solid organ or hematopoietic cell transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 55905
Actively Recruiting
3
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
4
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
5
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
9
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
10
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
C
Cabaletta Bio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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