This study is an open-label, single-arm, prospective, exploratory clinical trial involving patients with relapsed/refractory large B-cell lymphoma, aiming to preliminarily assess the safety and efficacy of CAR-T cell infusion.
This study is an open-label, single-arm, prospective, exploratory clinical trial targeting patients with relapsed/refractory large B-cell lymphoma. It plans to enroll 3 participants, where the investigator will administer a dose of 1-2×10\^6 CAR cells/kg of CAR-T cell infusion and follow up to observe related data on post-treatment adverse reactions and therapeutic effects, with the aim of preliminarily evaluating the safety and efficacy of the CAR-T cell infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Eligible participants receive lymphodepletion pretreatment 3 to 5 days before the therapy. The recommended pretreatment regimen is fludarabine (25-30 mg/m²) and cyclophosphamide (250-300 mg/m²). Antihistamines are administered before infusion. The plan is to enroll 3 patients with relapsed/refractory large B-cell lymphoma, who will be evaluated by the investigator and treated with 1-2 × 10\^6 CAR cells/kg of CAR-T cell infusion.
Incidence and severity of adverse events
Evaluate the possible adverse reactions recorded after CAR-T infusion, mainly including the number of cases, incidence, and severity of immune-related toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity, and hematologic toxicities.
Time frame: Within 28 days after CAR-T infusion
Efficacy indicators
Objective Response Rate (ORR) of tumors
Time frame: At 1 and 3 months after CAR-T infusion
Efficacy indicators
Complete Remission (CR) Rate
Time frame: At 1 and 3 months after CAR-T infusion
Cell Metabolic Kinetics Indicators
The maximum concentration (Cmax) of the study participants' CAR-T cells in peripheral blood
Time frame: On the 7th, 10th, 14th, and 28th days after treatment
Cellular Metabolic Kinetics Indicators
Time (Tmax) at which the study participants' CAR-T cells reach the maximum concentration in peripheral blood
Time frame: On the 7th, 10th, 14th, and 28th days after treatment
Cellular Metabolic Kinetics Indicators
Area under the curve (AUC28d) of peripheral blood CAR copy numbers in study participants on day 28.
Time frame: Day 28 after treatment
Exploratory indicators
CD19X CAR-T cell infusion products and the in vivo CAR-T single-cell phenotypes, clonal characteristics of study participants, as well as other indicators of interest to researchers, such as cytokine profiles.
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Time frame: The CAR-T single-cell phenotype and clonal characteristics are tested on the day of cell infusion. Follow-up is conducted on D10 and D28 after infusion, once a month from M2 to M3, every three months from M6 to Y1, and every three months from Y1 to Y2.