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.
The study will include the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Baseline testing, Lymphodepleting, C-CAR039 infusion, and Follow-up Visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
Peking Union Medical College Hospital
Beijing, Beijing/China, China
Incidence and severity of adverse events
Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria
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
Time to maximum concentration of C-CAR039 in the peripheral blood (Tmax)
Detect CAR-T copies number by qPCR
Time frame: Up to 24 Months after C-CAR039 infusion
Tlast of C-CAR039 in the peripheral blood after infusio (Tlast)
Detect CAR-T copies number by qPCR
Time frame: Up to 24 Months after C-CAR039 infusion
AUC0h-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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Progression-free survival (PFS)
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