The purpose of this study is to investigate the safety and tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.
This is a prospective, open-label, single-arm clinical study to evaluate the safety, tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).The study plans to explore across three dose levels (1.00 × 10\^6, 3.00 × 10\^6, 9.00 × 10\^6 CAR+ T cells/kg), and 6.00×10\^8 CAR+T cells as maximum dose, aiming to evaluate the safety, tolerability of anti-PD1 armored CD19 CAR-T Cells in r/r DLBCL, explore Maximum Tolerated Dose (MTD) and determine the recommended dose for Phase II. Besides, efficacy, pharmacokinetics and persistence profile of CAR-T cells are also study objectives.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Anti-PD1 armored CD19 CAR-T cells, single intravenous infusion
Suzhou Hongci Hematology Hospital
Suzhou, China
RECRUITINGIncidence of dose-limiting toxicity (DLT)
Dose-limiting toxicity for each subject
Time frame: 1 month after injection
AE/SAE
Incidence and severity of adverse events (AE), and serious adverse event (SAE)
Time frame: 1 month, 3 months, 6 months, 12 months after injection
Objective response rate (ORR)
Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months after injection
Overall survival (OS)
Defined as the time from the date of first infusion to death due to any cause
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months after injection
Duration of response (DOR)
The time from the date of first response (PR or better) to the date of disease progression after infusion
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months after injection
Progression-free survival (PFS)
The time from first infusion to the date of progression or death
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months after injection
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