Safety and Preliminary Efficacy of JK500 Cell Injection in Relapsed/Refractory Pediatric Acute Myeloid Leukemia

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 14, 2022

Primary Completion Date

November 30, 2023

Study Completion Date

December 31, 2025

Conditions
Acute Myeloid Leukemia, ChildhoodRelapsed LeukemiaRefractory Leukemia
Interventions
DRUG

JK500 cell injection,cyclophosphamide,Fludarabine

After enrollment, patients received JK500 cell injection infusion after reinduction therapy. Pretreatment regimen before cell infusion: intravenous infusion of cyclophosphamide 60mg/kg day -7, intravenous infusion of fludarabine 25mg/㎡/day day -6 to -2 days. In order to activate and expand circulating NK cells, on the day of each infusion of JK500 cells, the patients were first subcutaneously injected with 100WU/ m2 of interleukin (IL)-2 0.5h-1h in advance, for a total of 6 doses.

Trial Locations (1)

300020

RECRUITING

Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences, Tianjin

All Listed Sponsors
collaborator

Bejing Institute for Stem Cell and Regenerative Medicine

UNKNOWN

collaborator

Institute for Stem cell and Regeneration, Chinese Academy of Sciences

UNKNOWN

lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER