🏛️ Verified NIH Record • Updated 2026-07-08
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease (NCT06544330)
A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001 + STK-009) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Synthekine
🩺 Plain-English Summary (8th-Grade Level)
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
Who can join: Review the eligibility criteria below.
Location: HonorHealth Research Institute — Scottsdale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- HonorHealth Research Institute — Scottsdale, Arizona
- Hackensack University Medical Center — Hackensack, New Jersey
- Feinstein Institutes for Medical Research — Manhasset, New York
- Columbia University Irving Medical Center — New York, New York
- The Cleveland Clinic Foundation — Cleveland, Ohio
- Ohio State University Wexner Medical Center — Columbus, Ohio
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.