RecruitingPhase 1NCT06552416

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

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)

Sponsor

Marker Therapeutics, Inc.

Enrollment

40 participants

Start Date

Jun 16, 2025

Study Type

INTERVENTIONAL

Conditions

MDS Acute Myeloid Leukemia, in Relapse

Summary

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing MT-401-OTS, an off-the-shelf cell therapy product designed to target virus-associated proteins in cancer cells, in older patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are not good candidates for intensive chemotherapy. **You may be eligible if...** - You are 65 or older with AML or MDS that has returned after standard treatment - Your disease is intermediate or high-risk and has not fully responded to prior therapy - Your heart, liver, kidneys, and blood counts are functioning adequately - An MT-401-OTS product with a compatible HLA match is available for you **You may NOT be eligible if...** - You have leukemia that has spread to the brain or other organs (besides the liver/spleen) - You have had a prior stem cell transplant - You have HIV, active hepatitis B or C, or a serious autoimmune condition - You have severe heart failure or unstable heart rhythm - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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