This study is an open-label, single-arm, prospective clinical trial involving patients with relapsed/refractory B-cell lymphoma, aimed at evaluating the safety and efficacy of CAR-T cell infusion.
This study is an open-label, single-arm, prospective clinical trial involving patients with relapsed/refractory B-cell lymphoma. It plans to enroll 9-18 participants and uses a "3+3" dose-escalation design (with 3 dose groups: 1×10\^6, 2×10\^6, and 3×10\^6 CAR cells/kg) along with a dose-expansion study to administer CAR-T cell injection. Patients will be followed to observe adverse reactions and collect data on treatment efficacy, evaluating the safety and effectiveness of the CAR-T cell injection. The DLT observation period is 28 days after CAR-T cell infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Eligible participants should receive preconditioning 5 to 3 days before CAR-T cell infusion. The recommended preconditioning regimen is fludarabine (30 mg/m²/day, for 3 consecutive days) and cyclophosphamide (300 mg/m²/day, for 3 consecutive days) (Flu/Cy). Thirty minutes before infusion, prophylactic medication for allergic reactions should be administered: 25 mg of promethazine hydrochloride or 12.5 mg of diphenhydramine, either intramuscularly or orally. A '3+3' dose-escalation study design will be used, aiming to recruit 9-18 subjects with relapsed/refractory B-cell lymphoma.
Safety indicators
Six months after CAR-T infusion, analyze the recorded possible adverse reactions, mainly including the number of cases, incidence, and severity of immune-related toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity, hematologic toxicity, and organ toxicity. The incidence of DLT.
Time frame: 6 months after CAR-T infusion
Efficacy indicators
Tumor objective response rate (ORR) at 3 months follow-up after treatment.
Time frame: Three months after treatment
Efficacy indicators
Complete remission (CR) rate at 3 months post-treatment follow-up
Time frame: Three months after treatment
Efficacy indicators
Overall survival (OS) at 3 months post-treatment follow-up
Time frame: Three months after treatment
Efficacy indicators
Progression-free survival (PFS) at 3 months after treatment follow-up
Time frame: Three months after treatment
Cellular Metabolic Kinetics Indicators
Peripheral blood CAR copy number of research participants during follow-up
Time frame: On the fourth, seventh, tenth, fourteenth, twenty-first, and twenty-eighth days after retransfusion
Cellular Metabolic Kinetics Indicators
Maximum concentration (Cmax) of CAR-T cells in peripheral blood and the time to reach it
Time frame: Peripheral blood CAR copy number of research participants during follow-up
Cellular Metabolic Kinetics Indicators
Area under the CAR-T expansion curve AUC0-28d over 28 days
Time frame: 28 days after treatment
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