Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed/refractory CD19-positive hematologic malignancies.
Within each dose group, the next subject may be dosed after the previous subject has completed at least 14 days of safety observation. Following the assessment of dose-limiting toxicity (DLT) within 28 days after the last subject in each dose group completed a single dose, and upon approval by the Safety Review Committee (SRC) based on clinical safety data to proceed to the next dose group, enrollment and treatment for the next dose group may commence. If one DLT occurs among the first three subjects in a dose group, three additional subjects must be added to that group (bringing the total to six subjects for DLT assessment): If no DLT occurs in the 3 additional subjects, dose escalation continues. If 1 DLT occurs in the 3 additional subjects, dose escalation is halted. If \>1 DLT occurs in the 3 additional subjects, dose escalation is halted, and the dose must be reduced by one level to continue enrolling 3 subjects for DLT assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
A dose escalation was conducted using four fixed doses of LV009 injection solution: 0.3 × 10\^9, 0.6 × 10\^9, 1.2 × 10\^9, and 2.4 × 10\^9 TU.
PersonGen.Anke Cellular Therapeutice Co., Ltd.
Hefei, Anhui, China
RECRUITINGTEAE
According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: From the start of infusion of the study drug to 3 months after drug infusion
(Tmax)
Time to peak concentration of CD19 CAR-T expansion in peripheral blood following administration of LV009 injection
Time frame: Within 28 days after the transfusion and within 90 days after the transfusion
(Cmax)
Maximum concentration of CD19 CAR-T expansion in peripheral blood following administration of LV009 injection
Time frame: Within 28 days after the transfusion and within 90 days after the transfusion
AUC
Area under the curve of CD19 CAR-T expansion in peripheral blood 28 days after administration of LV009 injection
Time frame: Within 28 days after administration of LV009 injection
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