drugset / Trial / NCT06158828
Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML
Phase 1/2
Recruiting
68 enrolled
Washington University School of Medicine
Children's Discovery Institute · collabRising Tide Foundation · collabSt. Louis Children's Hospital Foundation · collabThe Leukemia and Lymphoma Society · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This trial represents a single institution phase I/II pilot study with the primary objective of establishing the safety and feasibility of generating and infusing ML NK cells after TCRαβ haplo-HCT.
Timeline
- Start
- 2024-11-15
- Primary completion
- 2028-09-15
- Completion
- 2030-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | — | Intravenous |
| Subject | Fludarabine | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Thiotepa | Other / unclassified | 5 mg/kg | Intravenous |
| Subject | Thymoglobulin | Protein / enzyme biologic | — | Intravenous |
| Subject | memory-like natural killer cells | Cell therapy | 0.5 cells/kg | — |
| Subject | memory-like natural killer cells | Cell therapy | 20 cells/kg | — |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 10 ug/kg | — |
| Background | Plerixafor | Small molecule | 0.16 mg/kg | Subcutaneous |
| Background | Plerixafor | Small molecule | 0.24 mg/kg | Subcutaneous |
| Background | TCR alpha beta / CD19+ depleted haploidentical hematopoietic progenitor cell graft | Cell therapy | — | — |
| Background | aldesleukin | Protein / enzyme biologic | 1 unknown | Subcutaneous |