This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19/22 CART cells combined with PD-1 Inhibitor in relapsed/refractory B Cell Lymphoma.
Though response rates have greatly improved with the development of Chimeric antigen receptor T cells (CART) therapy in refractory/relapsed B cell non-Hodgkin's lymphoma (R/R B-NHL), the response can't usually last long and relapse occurs in a large proportion of patients who receive CART cells infusion. The main reasons of relapse might be tumor antigen loss and a lack of CART cell persistence. Currently, preclinical studies have shown that there is a synergistic effect between CAR-T cell therapy and anti-PD1 pathway, and it did have efficacy in clinic. In parallel, the combined use of CART-19 and CART-22 cells has a better potential to reduce antigen escape and increase anti-tumor activity. Therefore, the combination of CD19/22 CART and PD-1 inhibitor is one of the ways to improve the therapeutic effect of CART cells. This study was conducted to explore the efficacy and safety of CD19/22 CART cells in R/R B-NHL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CD19/22 CART cells are administrated in a 3-day split-dose regimen at dose of 0.5- 2×10\*107 CART cells per kilogram of body weight.
Patients will receive Tislelizumab 200mg/dose every 3 weeks.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall response rate (ORR)
Number of patients who achieved response (complete response and partial response ) after treatment of CD19/22 CART combined with PD-1 inhibitor. Response will be assessed using the Lugano criteria.
Time frame: 1 year
Progression-free survival(PFS)
PFS will be assessed from the first CART cell infusion to progression,death or last follow-up.
Time frame: 1 year
Complete relapse rate(CR)
Number of patients who achieved complete response after treatment by CD19/22 CART combined with PD-1 inhibitor.
Time frame: 1 year
Duration of overall response (DOR)
Duration of overall response will be assessed from the first CAR-T cell infusion to progression,death or last follow-up.
Time frame: 1 year
Overall survival(OS)
OS will be assessed from the first CART cell infusion to death or last follow-up.
Time frame: 1 year
Incidence of treatment-related adverse events
The incidence rate of adverse events from the first day of preconditioning chemotherapy to 1 year after CART cells infusion
Time frame: 1 year
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