drugset / Trial / NCT04395092
Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)
Phase 2
Withdrawn
Kiadis Pharma
Blood and Marrow Transplant Clinical Trials Network · collabNational Cancer Institute (NCI) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabNational Institutes of Health (NIH) · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a Phase II, single arm, open label multicenter trial designed to investigate the use of haploidentical donor derived NK cells (K-NK002) for the treatment of patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are undergoing haploidentical donor bone marrow transplantation (HaploBMT). K-NK002 is a NK cell product derived from peripheral blood leukocytes collected from a related donor (HLA-haploidentical matched) and enriched for NK cells with depletion of CD3+ T-lymphocytes (T-cells) followed by enriched ex-vivo expansion and administered to the patient prior to and following BMT.
Timeline
- Start
- 2020-11-13
- Primary completion
- 2022-11
- Completion
- 2023-11
Outcome
Outcome not reported
Stopped: “The sponsor decided to withdraw this study”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | K-NK002 | Cell therapy | 1e+07 cells/kg | Intravenous |
| Subject | K-NK002 | Cell therapy | 1e+08 cells/kg | Intravenous |