🏛️ Verified NIH Record • Updated 2025-12-04

Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS (NCT06680752)

A Phase 1/2, Open-label, Multicenter Trial to Assess the Safety and Efficacy of ARD103 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: ARCE Therapeutics, Inc.

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

This is a phase I/2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (9 items).

Location: Novant Health Cancer Institute — Charlotte, North Carolina

Age range: 18 Years

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

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Participants with acute promyelocytic leukemia
  • Presence of active and clinically relevant central nervous system (CNS) disorder
  • Autoimmune disease requiring immunosuppressive treatment
  • Participants with known hepatic bridging cirrhosis
  • Currently active infection with hepatitis B or C
  • Previous treatment with investigational gene or cell therapy (including CAR therapy)
  • Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent)
  • Previous chemotherapy including biologic/targeted therapy or immunological agents directed to the pathology within 14 days prior to screening and all along the study duration

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

  • Novant Health Cancer Institute — Charlotte, North Carolina
  • Novant Health Cancer Institute — Winston-Salem, North Carolina
  • MD Anderson Cancer Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: +886-2-26581868

Email: contact@arcetherapeutics.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 ↗