This is a single-center, open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B-NHL patients.
This is a single-arm, open label, phase I study to evaluate the safety and preliminary efficacy of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma. 10 patients are planned to be enrolled. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of C-CAR039. Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to C-CAR039 infusion. All subjects who have received C-CAR039 infusion will be followed for up to 24 months
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
Tianjin Medical University Cancer Institute & Hosipital
Tianjin, Tianjin Municipality, China
Incidence and severity of adverse events (AE)
Incidence and severity of adverse events, including AE, Serious AE, AE of special interset (AESI)
Time frame: Up to 24 months after C-CAR039 infusion
Maximum concentration of C-CAR039 in the peripheral blood (Cmax)
Detect CAR-T copies number by qPCR
Time frame: Up to 24 Months after C-CAR039 infusion
The last of C-CAR039 in the peripheral blood after infusion (Tlast)
Detect CAR-T copies number by qPCR
Time frame: Up to 24 Months after C-CAR039 infusion
AUC0-28d of C-CAR039 in the peripheral blood (AUC0-28d)
Detect CAR-T copies number by qPCR
Time frame: Up to 28 days after C-CAR039 infusion
Time to reach the maximum plasma concentration (Tmax)
Detect CAR-T copies number by qPCR
Time frame: Up to 24 Months after C-CAR039 infusion
Overall Response rate (ORR)
Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria
Time frame: Up to 24 Months after C-CAR039 infusion
Duration of response (DOR)
The time from the date of first response (PR or better) to the date of disease progression or death after C-CAR039 infusion
Time frame: Up to 24 Months after C-CAR039 infusion
Progression-free survival (PFS)
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The time from C-CAR039 infusion to the date of progression as assessed by Lugano 2014 criteria or death
Time frame: Up to 24 Months after C-CAR039 infusion
Overall survival (OS)
The time from C-CAR039 infusion to the date of death
Time frame: Up to 24 Months after C-CAR039 infusion