This is an open label, single-site, dose-escalation study in up to 25 participants with relapse/refractory B-NHL. This study aims to evaluate the safety and efficacy of the treatment with PD1-CD19-CART.
PD1-CD19-CART is a kind of chimeric antigen T cell targeting CD19 with both CD19-CAR gene integration and also PD1 knockout by one-step gene-editing. After completion of study treatment, subject participation for this study will be followed up to 15 years post T cell infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Gene editing autologous T cells with anti-CD19 ScFv expression and knockout of PD1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MTD
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Time frame: up to 28 days after T cell infusion
RP2D
RP2D will be determined based on MTD and efficiency during the first 28 days of study treatment.
Time frame: up to 28 days after T cell infusion
Objective response rate (ORR)
Proportion of patients in whom a response among complete response and partial response as defined by standard disease-specific criteria, will be observed.
Time frame: Baseline up to 3 months after T cell infusion
Progress free survival (PFS)
Assessed using modified Lugano classification response criteria for lymphoma (2014)
Time frame: Baseline up to 3 months after T cell infusion
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