The currently CAR-T cell therapy in clinical practice largely depends on the expansion of CAR-T cells in vivo. However, the in vitro preparation process of CAR-T cells is complex and costly. In vivo CAR-T cell therapy eliminates the need for ex vivo preparation, significantly reducing treatment costs and procedural complexity. It enables immediate use, thereby improving patient accessibility. CD19 is stably overexpressed in more than 90% of B-cell malignancies. BAFF plays a core regulatory role in the survival, maturation, and homeostasis maintenance of B cells. BAFF-R is selectively expressed on the surface of mature B cell subsets and most B-cell malignancies. Currently, BAFF-R-based CAR-T therapy is in preclinical and early clinical research stages, demonstrating promising therapeutic potential, particularly offering a novel treatment option for patients with CD19-negative or drug-resistant B-cell tumors. The use of CD19/BAFF-R in vivo CAR-T cells as a new anti-tumor therapy may provide a new research direction for the treatment of relapsed/refractory B-cell acute leukemia/malignant lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
CD19/BAFF-R in vivo CAR-T cell intravenous infusion
Evaluate the safety of CD19/BAFF-R in vivo CAR-T cell therapy in relapsed/refractory B Cell Acute Leukemia/Malignant Lymphoma
the incidence and severity of immune therapy related toxic reactions (irAEs)
Time frame: up to one month after the CAR-T infusion
Evaluate the effcacy of CD19/BAFF-R in vivo CAR-T cell therapy in relapsed/refractory B Cell Acute Leukemia/Malignant Lymphoma
CR rate on M1 and M3
Time frame: one month and three month after the CAR-T infusion
Cell pharmacokinetics Dynamic indicators
CAR-T/T% by flow cytometry
Time frame: Day7, Day10, Day14, Day28 after the CAR-T infusion
long-term efficacy
OS
Time frame: up to one year after the CAR-T infusion
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