This is a single-arm, open-label clinical study evaluating the efficacy and safety of CD20/CD19/CD22 multi-targeted chimeric antigen receptor T-cell (CAR-T) injection in patients with relapsed/refractory B-cell lymphoma.
The primary objective of this study is to assess the safety and efficacy of CD19/CD20/CD22 muti-target CAR-T therapy in patients with relapsed or refractory B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.
Hebei Yanda Ludaopei Hospital
Hebei, China
Tongji Hospital of Tongji University
Shanghai, China
Incidence of Adverse events after CAR-T cells infusion [Safety and Tolerability]
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame: 28 days post administration of CAR-T-cells
Objective Response Rate (ORR), as assessed by Investigators
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Remission (CR) or Partial Remission (PR)
Time frame: 2 years post CAR T cell infusion
Duration of response (DOR), as assessed by Investigators
Duration of response (DOR) is defined as the time from the first documented objective response to the first documented disease progression or death.
Time frame: 2 years post CAR T cell infusion
Progression-free survival (PFS), as assessed by Investigators
Progression-free survival (PFS) was defined as the time from the date of infusion to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
Time frame: 2 years post CAR T cell infusion
Overall survival (OS)
Overall Survival (OS) was defined as the time from the date of first infusion to the date of death due to any cause.
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of CAR-T cells
Time at the maximal concentration(Tmax)
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of CAR-T cells
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Area under the concentration-time curve(AUC)
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of CAR-T cells
The maximal concentration of peripheral blood (Cmax)
Time frame: 2 years post CAR T cell infusion
Pharmacodynamics of CAR-T cells
Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, ferritin and CRP at each time point
Time frame: 2 years post CAR T cell infusion