This is a phase I, single center study to assess the efficacy and safety of ThisCART19A in adult with Non-Hodgkins Lymphoma in China.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
each patient will receive a dose level per body weight(kg) for only once.
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGDose limited toxicity(DLT) observation in patient with NHL during dose escalation stage
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 patient with NHL during dose expansion stage
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
Objective Response Rate during dose escalation stage and expansion stage
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
Duration of response(DOR) during dose escalation stage and expansion stage
The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR)
Time frame: 12 months
OS(overall survival) during dose escalation stage and expansion stage
Overall survival (OS) is defined as the time from the date of lymphodepletion until death from any cause.
Time frame: 12 months
Time to remission(TTR) during dose escalation stage and expansion stage
Time to remission(TTR) is defined as the time from the date of ThisCART19A infusion until the date of first remission.
Time frame: 12 months
Analysis the change characteristics of CART cell number and copy number during dose escalation and expansion stages
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Track CAR T cells expansion in patients after infusion
Time frame: 6 months
Analysis the change characteristics of cytokines and immune effect cells number during dose escalation and expansion stages
Analysis the effect cells and cytokines in patient after infusion
Time frame: 3 months
Analysis the severity and Incidence of Adverse Events in each dose level during dose expansion stage
Including more than or equal to grade 3 adverse events graded according to the NCI CTCAE v5.0, or the adverse events with special attention
Time frame: 3 months
Analysis the immunogenicity(anti-therapeutic antibody and neutralizing antibody) of CAR-T cells after infusion
Time frame: 12 months