This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of JD010 in adult patients with relapsed or refractory B cell hematologic malignancies. JD010 injection is a CD19-targeted chimeric antigen receptor modified natural killer cells (CAR-NK) derived from a healthy donor
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The relapsed/refractory B-cell hematologic malignancies patients will receive FC (F, Fludarabine, C, Cyclophosphamide) chemotherapy followed by 3 infusions of JD010 cells up to 2 dose levels (5x10\^6/kg, 2x10\^7/kg) after FC chemotherapy.
The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China
RECRUITINGDose limiting toxicities (DLTs)
Time frame: 1 Months
Treatment-related adverse events
Time frame: 3 months
Objective Response Rate (ORR)
Time frame: 3 months
Progression free survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 12 months
Proportion of subjects with minimal-residual disease (MRD) negative response
Time frame: 12 months
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