🏛️ Verified NIH Record • Updated 2026-08-18

Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis (NCT06655896)

A Phase II, Multi-part, Randomized, Open-label, Assessor-blinded, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Rituximab Treatment in Participants With Severe Refractory Diffuse Cutaneous Systemic Sclerosis

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.

Who can join: Review the eligibility criteria below.

Location: UCLA — Los Angeles, California

Age range: 18 Years to 70 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (94 Sites)

Showing the first 25 of 94 sites.

  • UCLA — Los Angeles, California
  • UCSF — San Francisco, California
  • UCSF — San Francisco, California
  • Sutter Health Network — San Pablo, California
  • FL Medical Clinic Orlando Health — Zephyrhills, Florida
  • Northwestern University — Chicago, Illinois
  • University Of Iowa — Iowa City, Iowa
  • Boston Medical Center — Boston, Massachusetts
  • Michigan Med University of Michigan — Ann Arbor, Michigan
  • University of Minnesota — Minneapolis, Minnesota
  • James Cancer Hospital — Columbus, Ohio
  • Oregon Health Sciences University — Portland, Oregon
  • Avera Cancer — Sioux Falls, South Dakota
  • LDS Hospital — Salt Lake City, Utah
  • Novartis Investigative Site — Córdoba, Córdoba Province
  • Novartis Investigative Site — CABA,
  • Novartis Investigative Site — Camperdown, New South Wales
  • Novartis Investigative Site — Darlinghurst, New South Wales
  • Novartis Investigative Site — Graz,
  • Novartis Investigative Site — Vienna,
  • Novartis Investigative Site — Vienna,
  • Novartis Investigative Site — Ghent,
  • Novartis Investigative Site — Salvador, Estado de Bahia
  • Novartis Investigative Site — Curitiba, Paraná
  • Novartis Investigative Site — Barretos, São Paulo

📞 Contact the Study Coordinator

Phone: (888) 669-6682

Email: novartis.email@novartis.com

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

💰 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 § 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.

💡 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.
🏛️ View Official NIH Record ↗