Donor-derived multi-antigen T-cell therapy after hypomethylating bridging for relapsed AML post-transplant
Official title: Phase 2 clinical trial of a novel T cell therapy following bridging therapy with hypomethylating agents for relapsed AML patients post-stem cell transplant
Funded at Marker Therapeutics, INC. · NIH-11181329 · Data updated 2026-11-12
A donor-derived T-cell treatment given after hypomethylating drugs for people whose AML has returned after a stem cell transplant.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Marker Therapeutics, INC. NIH-funded |
| Lab location | 1 site (Houston, United States) |
| Project start | August 10, 2023 |
| Project end | July 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $664,838 |
| NIH project number | 5R44CA285177-03 |
| Project ID | NIH-11181329 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults with relapsed AML after an allogeneic hematopoietic stem cell transplant who can receive hypomethylating bridging therapy and donor-derived cell products.
✕Less likely to help
Patients without an available or HLA-matched stem cell donor, those with other active serious illnesses, or those unable to tolerate bridging therapy may not benefit or be eligible.
What this research studies
This Phase 2 program gives people with AML that returned after a stem cell transplant a course of hypomethylating drugs followed by an infusion of MT-401, a T-cell product made from the original stem cell donor. MT-401 contains T cells that target four leukemia-associated antigens so they can attack cancer cells through natural T-cell receptors and engage other parts of the immune system. The product is made from donor apheresis material and has shown targeted killing of AML cells in lab and animal tests, and similar multi-antigen T-cell therapies have been given safely to more than 170 patients. The trial will monitor safety and how well the therapy controls leukemia after the transplant.
Why it matters
Potential benefit: If successful, this approach could lower relapse rates and extend survival for patients whose AML returns after transplant.
How similar studies have gone: Related multi-antigen T-cell therapies have shown targeted tumor killing in preclinical studies and been administered safely to over 170 patients, but MT-401's effectiveness in this specific post-transplant AML setting remains to be shown.
Where this research is happening
-
Marker Therapeutics, INC.
Houston, United States Active
Researchers
- Principal investigator: Vera, Juan Fernando — Marker Therapeutics, INC.
- Study coordinator: Vera, Juan Fernando
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.