๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-08

Safety of MT-401-OTS in Patients With Relapsed AML or MDS (NCT06552416)

A Phase 1 Study of Allogenic Off-the-Shelf Multi-Tumor-Associated Antigen-Specific T Cell Products (MT-401-OTS) Administered to Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndromes (RAPID)

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Marker Therapeutics, Inc.

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

This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or \</= 10% blast following prior induction therapy or at least 4 cycles of nonintensive therapy and 2) those with high- or very-high-risk MDS per 2023 IWG criteria and who have residual disease with \</= 10% blasts following treatment with an HMA-based therapy.

Who can join: Review the eligibility criteria below.

Location: City of Hope Center (City of Hope National Medical Center, City of Hope Medical Center) โ€” Duarte, California

Age range: 65 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 (3 Sites)

  • City of Hope Center (City of Hope National Medical Center, City of Hope Medical Center) โ€” Duarte, California
  • Moffitt Cancer Center โ€” Tampa, Florida
  • KU Cancer Center โ€” Kansas City, Kansas

๐Ÿ“ž Contact the Study Coordinator

Phone: (713) 400-6400

Email: pallison@markertherapeutics.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†—