This is a single arm study to evaluate the safety and efficacy of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for Relapsed/Refractory B-Cell Lymphoma
The subject has voluntarily signed the informed consent form with full consent, and is willing and able to comply with the scheduled visits, study treatments, laboratory tests, and other trial procedures
Lymphoma cells confirmed to express CD19 and/or CD20 antigen by immunophenotyping or histopathological immunohistochemistry
B-cell lymphomas include: aggressive B-cell lymphomas (LBCL, BL, MCL) and indolent B-cell lymphomas (CLL/SLL, FL, MZL, LPL, HCL)
Relapsed/refractory B-cell lymphoma: For patients with aggressive lymphoma, disease stable for ≤12 months or disease progression after achieving best response following at least first- and second-line pharmacotherapy; or disease progression or relapse within ≤12 months after autologous stem cell transplantation. For patients with indolent lymphoma, disease progression, relapse or transformation following at least three lines of prior therapy
Severe cardiac insufficiency with left ventricular ejection fraction < 50%
History of severe pulmonary function-impairing diseases
Concomitant other advanced malignant neoplasms
Concomitant severe infection that cannot be effectively controlled
Sequential
CD19/CD20 Tandem Dual CAR-T
GeneticEach subject will be infused with single dose of CD19/CD20 Tandem Dual CAR-T. A classic "3+3" dose escalation will be employed. The low dose is 2×10\^6 / kg, the medium dose is 4×10\^6 /kg, and the high dose is 6×10\^6 /kg.
According to the incidence of treatment-related adverse events (AEs) to evaluate the safety of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for CD20/CD19 positive relapsed/refractory B-Cell lymphoma.
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for CD20/CD19 positive relapsed/refractory B-Cell lymphoma.
According to the objective response rate (ORR) to evaluate the efficacy of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for CD20/CD19 positive relapsed/refractory B-Cell lymphoma.
Overall Response Rate (ORR) Description:For B-cell lymphoma, ORR is defined according to the Lugano Classification for Lymphoma Response Assessment. ORR represents the proportion of patients achieving complete response (CR) or partial response (PR).
According to the pharmacokinetics (number of CAR-T cells in peripheral blood was measured to evaluate the persistence of CAR-T cells) to explore the kinetics and clonal evolution of CD19/CD20 Tandem Dual CAR-T.
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This trial is not recruiting at the moment. You can still explore other options:
