Skip to content
Bored Studies
RecruitingPhase 2/Phase 3

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

Cabaletta Bio · NCT06328777

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
37
US sites recruiting
10
Study start
July 2, 2024
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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

Being studied: CABA-201; CABA-201

Conditions: Systemic Sclerosis; Scleroderma; Interstitial Lung Diseases

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Yale University

    New Haven, CT 06519

    Site contact: Diane Documet · diane.documet@yale.edu

  • Mayo Clinic Florida

    Jacksonville, FL 55905

    Site contact: Gabrielle Pariseau · 904-953-5549 · Pariseau.Gabrielle@mayo.edu

  • Northwestern Memorial Hospital

    Chicago, IL 60611

    Site contact: Kaitlin King · 312-695-0990 · autoimmunesct@nm.org

  • The University of Chicago Medical Center

    Chicago, IL 60637

    Site contact: Dequana Jones · 773-834-5726 · Dequana.Jones@bsd.uchicago.edu

  • University of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: Theresa Howard · 913-588-0653 · Thoward2@kumc.edu

  • University of Michigan

    Ann Arbor, MI 48109

    Site contact: Lynne Bischoff · lloisros@med.umich.edu

  • Mayo Clinic Rochester

    Rochester, MN 55905

    Site contact: Christi Sagen · 507-422-3425 · sagen.christine@mayo.edu

  • Columbia University Irving Medical Center

    New York, NY 10032

    Site contact: Gaby Ycaza · 212-342-2751 · mgy2107@cumc.columbia.edu

  • University of Rochester

    Rochester, NY 14642

    Site contact: Chelsey LoMonaco · 585-402-2916 · Chelsey_lomonaco@urmc.rochester.edu

  • Duke University

    Durham, NC 27710

    Site contact: Khalia Stewart · 919-660-2280 · Khalia.stewart@duke.edu

Study contacts (from the official record)

  • Cabaletta Bio · 267 759 3100 · clinicaltrials@cabalettabio.com
RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy… (NCT06328777) | Bored Studies