This is a single arm, open-label study to evaluate the safety, tolerance and efficacy of CD20 CAR-T Cells in patients with relapsed and refractory B cell non-Hodgkin Lymphoma. Subjects receive a single intravenous infusion of CD20-CART cells per treatment course.
The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD20 CART cells per treatment course. The dose escalation test was designed to evaluate the four dose levels of CD20-CART (1 × 10 \^ 6 cells/kg,2 × 10 \^ 6 cells/kg,4 × 10 \^ 6 cells/kg,8 × 10 \^ 6 cells/kg). Each CD20-CART infusion will be carried out on day 0. Each subject was observed for at least 4 weeks after the last infusion. If there was no dose-limited toxicity (DLT), it is necessary to continue multiple treatment courses at this dose level. The detailed administration time and dose were decided by the researchers. The observation period was 4 weeks after the end of the course of treatment. If 2 or more cases of DLT occurred at a certain dose level, the prior dose level was the maximum tolerable dose of (MTD). If one case of DLT occurred, 3 subjects were added to the group. If there were no DLT in 3 cases, the next dose level would be estimated. If at least 1 case of DLT occurred in the 3 cases, the prior dose was the maximum tolerated dose of (MTD). If there were no DLT at the maximum dose, the maximum tolerant dose was the maximum dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD20 CART cells per treatment course. The dose escalation test was designed to evaluate the four dose levels of CD20-CART (1 × 10 \^ 6 cells/kg,2 × 10 \^ 6 cells/kg,4 × 10 \^ 6 cells/kg,8 × 10 \^ 6 cells/kg).
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGThe Adverse events (AEs)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 4 weeks
Expression of CD20 CART cells
Expression of CD20 CART cells detected by flow cytometry in blood and bone marrow
Time frame: 2 years
Detection of CD20 CART cells
Detection of CD20 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
Time frame: 2 years
Graft Activity Endpoint Detection
The vector copy number (VCN) of the exogenous CAR vector in the blood and bone marrow.
Time frame: 2 years
Overall remission rate (ORR)
Time frame: 2 years
Complete Remission (CR)
Time frame: 2 years
Partial Remission (PR)
Time frame: 2 years
To evaluate the duration of remission (DOR)
Time frame: 2 years
To evaluate the Progression-free survival (PFS)
Time frame: 2 years
To evaluate the Overall survival (OS)
Time frame: 2 years
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