drugset / Trial / NCT05519384
Safety and Preliminary Efficacy of JK500 Cell Injection in Relapsed/Refractory Pediatric Acute Myeloid Leukemia
Phase 0
Unknown
12 enrolled
Institute of Hematology & Blood Diseases Hospital, China
Bejing Institute for Stem Cell and Regenerative Medicine · collabInstitute for Stem cell and Regeneration, Chinese Academy of Sciences · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a prospective, single-center, single-arm exploratory clinical study, aiming to complete the preliminary clinical observation of 12 children with relapsed/refractory acute myeloid leukemia treated with JK500 cell injection to evaluate the safety of clinical infusion and the initial efficacy of JK500 cell injection in the treatment of children with relapsed/refractory acute myeloid leukemia.
Timeline
- Start
- 2022-09-14
- Primary completion
- 2023-11
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JK500 cell injection | Cell therapy | 1e+06 cells/kg | — |
| Subject | JK500 cell injection | Cell therapy | 5e+06 cells/kg | — |
| Subject | JK500 cell injection | Cell therapy | 3e+07 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |