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.
1. Subjects voluntarily participate in clinical research and sign informed consent.
2. Adult subjects (age ≥18 ) with relapsed or refractory diffuse large B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).
3. Expected survival ≥ 3 months.
4. At least one measurable lesion as per revised IWG response criteria for malignant lymphom (2014 Lugano criteria).
1. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.
2. Infectious disease(HIV, Active Tuberculosis ect.).
3. Active infection: hepatitis B, hepatitis C.
4. Abnormal vital signs or refuse to receive examination.
Single group
Anti-PD1 armored CD19 CAR-T cells
Biological/VaccineAnti-PD1 armored CD19 CAR-T cells, single intravenous infusion
Incidence of dose-limiting toxicity (DLT)
Dose-limiting toxicity for each subject
AE/SAE
Incidence and severity of adverse events (AE), and serious adverse event (SAE)
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
Overall survival (OS)
Defined as the time from the date of first infusion to death due to any cause
Duration of response (DOR)
The time from the date of first response (PR or better) to the date of disease progression after infusion
Progression-free survival (PFS)
The time from first infusion to the date of progression or death
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