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

🧪 Interventions in This Study

• MT-401-OTS (DRUG)

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).

1. General
2. Must be ≥ 65 years of age and capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol, at the time of signing the ICF
3. Must have a life expectancy ≥ 12 weeks
4. Must have an ECOG performance status of 0-2
5. Must have available MT-401-OTS product with a ≥ 2/8 HLA match Disease Characteristics
6. For participants with AML:
7. Must have a confirmed diagnosis of AML or MDS/AML per 2022 WHO Classification of Haematolymphoid Tumours: Myeloid and Histiocytic/Dendritic Neoplasms or 2022 International Consensus Criteria
8. Must have intermediate or high-risk disease based on ELN 2022 criteria.
9. If no targetable mutation is present, must have received 1 prior standard regimen with at least 4 cycles of standard therapy containing an HMA or a standard cytarabine-containing induction therapy
10. If targetable mutation is present, must have received a regimen that includes commercially available targeted therapy unless unable to tolerate or the participant declines (must be documented in the informed consent). If targeted therapy was not administered as part of first-line of therapy, a second regimen is allowed.
11. Must have either: ≤ 10% bone marrow blasts and ≤ 5% peripheral blasts during screening and not be considered to have hyperproliferating disease at diagnosis or after treatment OR Evidence of MRD based on evaluation at a local laboratory
12. For participants with MDS:

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

📍 All Participating Trial Locations (3 Sites)

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

📞 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.

💰 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.
• 💵 Compensation indicated: Once a suitable MT-401-OTS product is confirmed, the participant will receive a lymphodepleting conditioning regimen consisting of fludarabine and cyclophosphamide daily from Day -7 to Day -5.

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• Venetoclax to Augment Epigenetic Modification and Chemotherapy — Milwaukee, Wisconsin
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💡 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.