๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-14

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 (NCT06328777)

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

๐ŸŸข Recruiting Phase2 / Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Cabaletta Bio

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: Yale University โ€” New Haven, Connecticut

Age range: 18 Years to 75 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (10 Sites)

  • Yale University โ€” New Haven, Connecticut
  • Mayo Clinic Florida โ€” Jacksonville, Florida
  • Northwestern Memorial Hospital โ€” Chicago, Illinois
  • The University of Chicago Medical Center โ€” Chicago, Illinois
  • University of Kansas Medical Center โ€” Kansas City, Kansas
  • University of Michigan โ€” Ann Arbor, Michigan
  • Mayo Clinic Rochester โ€” Rochester, Minnesota
  • Columbia University Irving Medical Center โ€” New York, New York
  • University of Rochester โ€” Rochester, New York
  • Duke University โ€” Durham, North Carolina

๐Ÿ“ž Contact the Study Coordinator

Phone: (267) 759-3100

Email: clinicaltrials@cabalettabio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—