drugset / Trial / NCT07256210
Feasibility and Safety of Donor-derived NK-cell Infusions for Leukemia Relapse Prophylaxis After Hematopoietic Stem Cell Transplantation
Phase 2
Recruiting
15 enrolled
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
NaSingle-groupOpen-labelTreatment
Summary
This pilot clinical trial aims to evaluate the feasibility, adverse reactions and maximum tolerated dose of mbIL21 ex vivo-expanded donor-derived NK-cell infusions before and after haploidentical or matched-related hematopoietic stem cell transplantation in a cohort of pediatric and young adult patients with chemorefractory or minimal residual disease (MRD) positive acute leukemia.
Timeline
- Start
- 2025-05-09
- Primary completion
- 2026-10
- Completion
- 2027-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Donor-derived Natural Killer Cell | Cell therapy | 5e+06 cells/kg | — |
| Subject | Donor-derived Natural Killer Cell | Cell therapy | 1e+07 cells/kg | — |
| Subject | Donor-derived Natural Killer Cell | Cell therapy | 2e+07 cells/kg | — |
| Subject | Donor-derived Natural Killer Cell | Cell therapy | 3e+07 cells/kg | — |