This is a phase 1/2, open-label study to assess the efficacy, safety and pharmacokinetics of ThisCART19A (Allogeneic Anti CD19 CAR-T) in patients with refractory or relapsed CD19 positive B cell Lymphoma.
This is a phase 1/2, single-center, nonrandomized, open-label, dose-escalation and dose-expansion study to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A in patients with r/r CD19 positive B cell Lymphoma and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile. AIDS-related B-cell lymphoma were not excluded from this clinical trial. Before initiating ThisCART19A infusion, subjects will be administered lymphodepletion chemotherapy composed of fludarabine、cyclophosphamide and VP-16. At Day 0 of the Treatment Period, subjects will receive an intravenous (IV) infusion of ThisCART19A. All subjects are monitored during the treatment period through Day 42. All subjects who receive a dose of ThisCART19A will be followed up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Single dose of Allogeneic Anti-CD19 CAR T cells (ThisCART19A) will be infused after the lymphodepletion conditioning of Fludarabine, Cyclophosphamide and Etoposide.
Fludarabine is used for lymphodepletion.
Cyclophosphamide is used for lymphodepletion.
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Dose limited toxicity(DLT) observation in patient with r/r B cell Lymphoma
DLT was defined as CAR T cells-related events with onset within first 28 days following infusion.
Time frame: 28 days
The incidence of all grade TEAEs and ≥3 grade TEAEs
Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs
Time frame: Up to 2 years after ThisCART19A infusion
Objective Response Rate
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: Up to 2 years after ThisCART19A infusion
Duration of response (DOR)
DOR is defined as the date of their first CR or PR (which is subsequently confirmed) to PD assessed by investigators and based on the Lugano 2014 assessment criterion for r/r B cell Lymphoma, or death regardless of cause.
Time frame: Up to 2 years after ThisCART19A infusion
Progress-free survival (PFS)
PFS is defined as the time from the ThisCART19A infusion date to the date of disease progression assessed by investigators and based on the Lugano 2014 assessment criterion, or death any cause.
Time frame: Up to 2 years after ThisCART19A infusion
TTR (Time to response)
TTR is defined as the time from ThisCART19A infusion to first assessed CR or PR based on the Lugano 2014 assessment criterion.
Time frame: Up to 2 years after ThisCART19A infusion
OS (Overall survival)
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Etoposide is used for lymphodepletion.
Overall survival (OS) is defined as the time from the date of lymphodepletion until death from any cause.
Time frame: Up to 2 years after lymphodepletion