This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).
This is a dose-escalation study of CD123-targeted chimeric antigen receptor modified natural killer cells (CAR-NK) derived from a healthy donor. The relapsed/refractory AML patients will receive FC (F, Fludarabine, C, Cyclophosphamide) chemotherapy followed by infusion of JD123 injections. No graft-versus-host disease (GVHD) prevention will be conducted before or after infusion. Dose-limiting toxicity, incidence of adverse events, disease response and PK/PD will be detected post-infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
JD123 injection is an universal Off-the-shelf CD123-targeted chimeric antigen receptor modified natural killer cells (CAR-NK) therapy derived from a healthy donor.
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITING1-month DLTs
Dose limiting toxicities (DLTs)
Time frame: 1-month
3-month CR/CRi
Complete response (CR) or Complete remission with incomplete recovery(CRi)
Time frame: 3-month
1-year PFS
Progression free survival(PFS)
Time frame: 1-year
1-year OS
Overall Survival (OS)
Time frame: 1-year
1-year MRD(-)
Proportion of subjects with minimal-residual disease (MRD) negative response
Time frame: 1-year
3-month AUC
The area under the concentration time-curve (AUC) of CD123-CAR-NK cells
Time frame: 3-month
3-month Peak
Peak levels of CD123-CAR-NK cells (maximum concentration or Cmax)
Time frame: 3-month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.