What this study is
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
What's being tested
- CABA-201
Intervention · BIOLOGICAL
- CABA-201
Intervention · BIOLOGICAL
Both interventions
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Study details
- 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
- Sponsor
- Cabaletta Bio
- Conditions
- Systemic Sclerosis · Scleroderma · Interstitial Lung Diseases
- Enrolling
- 37 people
- Starts
- 2024-07-02
- Est. completion
- 2029-07
- Design
- Open-label, non-randomized, single group, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou 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, or cardiac involvement
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (10)
10 openYale University
New Haven, Connecticut, United States
- Diane Documet · Contactdiane.documet@yale.edu
- Dr. Monique Hinchcliff, MD, MS · Principal investigator
RecruitingMayo Clinic Florida
Jacksonville, Florida, United States
- Gabrielle Pariseau · Contact904-953-5549Pariseau.Gabrielle@mayo.edu
- Dr. Andy Abril, MD · Principal investigator
RecruitingNorthwestern Memorial Hospital
Chicago, Illinois, United States
- Kaitlin King · Contact312-695-0990autoimmunesct@nm.org
- Dr. George Georges, MD · Principal investigator
RecruitingThe University of Chicago Medical Center
Chicago, Illinois, United States
- Dequana Jones · Contact773-834-5726Dequana.Jones@bsd.uchicago.edu
- Dr. Michael Macklin, MD · Principal investigator
RecruitingUniversity of Kansas Medical Center
Kansas City, Kansas, United States
- Theresa Howard · Contact913-588-0653Thoward2@kumc.edu
- Dr. Paul Schmidt, MD · Principal investigator
RecruitingUniversity of Michigan
Ann Arbor, Michigan, United States
- Lynne Bischoff · Contactlloisros@med.umich.edu
- Contactssc-coordinator@umich.edu
- Monalisa Ghosh, MD · Principal investigator
RecruitingMayo Clinic Rochester
Rochester, Minnesota, United States
- Christi Sagen · Contact507-422-3425sagen.christine@mayo.edu
- Ashima Makol, MD · Principal investigator
RecruitingColumbia University Irving Medical Center
New York, New York, United States
- Gaby Ycaza · Contact212-342-2751mgy2107@cumc.columbia.edu
- Elana Bernstein, MD · Principal investigator
RecruitingUniversity of Rochester
Rochester, New York, United States
- Chelsey LoMonaco · Contact585-402-2916Chelsey_lomonaco@urmc.rochester.edu
- Benjamin Korman, M.D. · Principal investigator
RecruitingDuke University
Durham, North Carolina, United States
- Khalia Stewart · Contact919-660-2280Khalia.stewart@duke.edu
- Michelle Mack · Contact919-613-1107Michelle.mack@duke.edu
- Ankoor Shah, MD · Principal investigator
Recruiting
Study team
Sponsor
Cabaletta Bio
Study ID CAB-201-003
Study director
Medical Director
Cabaletta Bio
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.