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
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
1 other identifier
interventional
12
1 country
10
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2024
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2024
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedStudy Start
First participant enrolled
July 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
April 24, 2026
April 1, 2026
5 years
March 19, 2024
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate incidence of adverse events
Incidence and severity of AEs
Up to 28 days after CABA-201 infusion
Secondary Outcomes (4)
To evaluate adverse events and laboratory abnormalities
Up to 156 weeks
To characterize the pharmacodynamics (PD)
Up to 156 weeks
To characterize the pharmacokinetics (PK)
Up to 156 weeks
To evaluate efficacy
Up to 156 weeks
Study Arms (1)
CABA-201
EXPERIMENTALSevere 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
Interventions
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cabaletta Biolead
Study Sites (10)
Yale University
New Haven, Connecticut, 06519, United States
Mayo Clinic Florida
Jacksonville, Florida, 55905, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
Duke University
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Cabaletta Bio
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2024
First Posted
March 25, 2024
Study Start
July 2, 2024
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2029
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share