This is a single-center, open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B cell Non-Hodgkin's Lymphoma patients.
The study includes the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Baseline testing, Lymphodepletion, C-CAR039 infusion, Dose-limiting toxicity observation and Follow-up Visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Autologous 2nd generation CD19/CD20-directed Chimeric Antigen Receptor T Cells, single infusion intravenously
Peking University Cancer Hospital
Beijing, China
Safety Observation
Incidence of adverse events after C-CAR039 infusion. Incidence and severity of adverse events according to NCI-CTCAE v5.0 criteria, including Dose Limited Toxicity
Time frame: up to 24 Months. Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria, including dose-limiting toxicity (DLT) and laboratory abnormalities.
Maximum concentration (Cmax) of C-CAR039 in the peripheral blood.
Detect Chimeric Antigen Receptor-T copies number by quantitative polymerase chain reaction(qPCR).
Time frame: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
Time to maximum concentration (Tmax) of C-CAR039 in the peripheral blood.
Detect Chimeric Antigen Receptor-T copies number by qPCR.
Time frame: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
Peripheral blood duration of C-CAR039 in the peripheral blood after infusion.
Detect Chimeric Antigen Receptor-T copies number by qPCR.
Time frame: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
Area under the curve 0h-28d of C-CAR039 in the peripheral blood.
Detect Chimeric Antigen Receptor-T copies number by qPCR.
Time frame: Baseline, Days 4, 7, 10 and weeks 2, 3, 4
Overall response rate (ORR)
Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria.
Time frame: 4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
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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
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: 4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Overall survival (OS)
The time from C-CAR039 infusion to the date of death.
Time frame: up to 24 months