This is an open label, phase I study to assess the safety and efficacy of ThisCART19A in patients with AIDS related B cell lymphoma/lympholeukemia.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
ThisCART19A is a new type CAR-T cells therapy for patients with lymphoma and lympholeukemia
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGDose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Time frame: 28 days
Objective Response rate in patients with AIDS related lymphoma
The incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment
Time frame: 12 months
The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion
Track CAR-T cells expansion in patients after infusion
Time frame: 6 months
Analysis the change characteristics of cytokines and immune effect cells number in patients after infusion
Analysis the effect cells and cytokines in patients after infusion
Time frame: 3 months
Analysis the severity and Incidence of Adverse Events in each dose level
Including more than or equal to grade 3 adverse events graded according to the NCI CTCAE v5.0, the adverse events with special consideration
Time frame: 12 months
Analysis the immunogenicity(Anti-therapeutic antibody and neutralizing antibody) of CAR-T cells in patients after infusion
Analysis the Anti-therapeutic antibody and neutralizing antibody level after infusion
Time frame: 24 months
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