drugset / Trial / NCT06552416
Safety of MT-401-OTS in Patients With Relapsed AML or MDS
Phase 1
Recruiting
40 enrolled
Marker Therapeutics, Inc.
City of Hope National Medical Center · collabFDA Office of Orphan Products Development · collabH. Lee Moffitt Cancer Center and Research Institute · collabUniversity of Kansas Medical Center · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2025-06-16
- Primary completion
- 2029-09
- Completion
- 2029-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MT-401-OTS | Cell therapy | 5e+07 cells | Intravenous |
| Subject | MT-401-OTS | Cell therapy | 1e+08 cells | Intravenous |
| Subject | MT-401-OTS | Cell therapy | 2e+08 cells | Intravenous |
| Subject | MT-401-OTS | Cell therapy | 4e+08 cells | Intravenous |