Recruiting
Phase 2
Phase 3

CABA-201

Sponsor:

Cabaletta Bio

Code:

NCT06328777

Conditions

Systemic Sclerosis

Scleroderma

Interstitial Lung Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CABA-201

CABA-201

Study Details

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

Conditions

Systemic Sclerosis

Scleroderma

Interstitial Lung Diseases

Study ID

NCT06328777

Start date

Jul 2, 2024

Status verified date

Aug, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

37 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CABA-201 Phase 1/2

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

experimental: CABA-201 Phase 2b - Sub-study

Infusion of CABA-201 with preconditioning in subjects with SSc

Interventions

CABA-201

Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide

CABA-201

Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide

Primary outcome measure

  • Phase 1/2: To evaluate incidence of adverse events [ Time Frame: Up to 28 days after CABA-201 infusion ]
  • Phase 2b Sub-study: To evaluate the efficacy of CABA-201 on % predicted forced vital capacity (FVC) in SSc-ILD subjects [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

Cabaletta Bio

267 759 3100clinicaltrials@cabalettabio.com

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Stephanie Perez

860-992-2908s.perez@yale.edu

Principal Investigator:

Dr. Monique Hinchcliff, MD, MS

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 55905

Contacts

Gabrielle Pariseau

904-953-5549Pariseau.Gabrielle@mayo.edu

Principal Investigator:

Dr. Andy Abril, MD

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kaitlin King

312-695-0990autoimmunesct@nm.org

Principal Investigator:

Dr. George Georges, MD

The University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Dequana Jones

773-834-5726Dequana.Jones@bsd.uchicago.edu

Principal Investigator:

Dr. Michael Macklin, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Theresa Howard

913-588-0653Thoward2@kumc.edu

Principal Investigator:

Dr. Paul Schmidt, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Lynne Bischoff

lloisros@med.umich.edu

ssc-coordinator@umich.edu

Principal Investigator:

Monalisa Ghosh, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Christi Sagen

507-422-3425sagen.christine@mayo.edu

Principal Investigator:

Ashima Makol, MD

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Gaby Ycaza

212-342-2751mgy2107@cumc.columbia.edu

Principal Investigator:

Elana Bernstein, MD

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Chelsey LoMonaco

585-402-2916Chelsey_lomonaco@urmc.rochester.edu

Principal Investigator:

Benjamin Korman, M.D.

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Khalia Stewart

919-660-2280Khalia.stewart@duke.edu

Michelle Mack

919-613-1107Michelle.mack@duke.edu

Principal Investigator:

Ankoor Shah, MD

More Information

Sponsor

Cabaletta Bio

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • CABA-201
  • autoimmune disease
  • anti-CD19 CAR-T therapy
  • systemic sclerosis
  • scleroderma
  • Interstitial lung disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cabaletta Bio on 2026-08-17.