The main research objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of UTAA09 cell preparation in the treatment of relapsed/refractory B-cell non Hodgkin's lymphoma patients. The secondary research objective is to explore the clinical efficacy of UTAA09 injection after administration and to explore the content of CD19 positive B cells in peripheral blood after UTAA09 injection administration.
Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into 3 x 108\~1 x 1010 CD19-CAR - γδT cells.
PersonGen.Anke Cellular Therapeutice Co., Ltd.
Hefei, Anhui, China
RECRUITINGThe incidence of dose limiting toxicity (DLT )
The incidence, severity, and types of dose limiting toxicity
Time frame: 28 days after infusion
The incidence of TEAEs
The incidence, severity, and types of adverse events that occur during treatment
Time frame: 28 days after infusion
ORR
Evaluate the overall response rate based on the efficacy criteria of Lugano 2014
Time frame: 24 months after infusion
PFS
Evaluate the progression free survival based on the efficacy criteria of Lugano 2014
Time frame: 24 months after infusion
OS
Evaluate the overall survival based on the efficacy criteria of Lugano 2014
Time frame: 24 months after infusion
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