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Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells

B-cell Non Hodgkin Lymphoma Clinical Trial

Official title:
Prospective, Multicenter, Open, One-arm Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells

Clinical Trial Summary

To evaluate the ORR (CR+PR) of R/R B-NHL subjects treated with BTKi+Anti-CD19 CAR T cells.

Clinical Trial Description

The most successful application of CAR-T cell technology in clinical practice is for the treatment of hematologic malignancies, which may be related to the strong specificity of tumor-associated antigen and the weak immunosuppressive effect of tumor microenvironment. CD19 is specifically expressed in B cells and is expressed in all stages of B-cell development and differentiation and in most B-cell tumors, but not in hematopoietic stem cells and other cells. CD19 is a promising target for B-cell tumors and is currently a hot spot in CAR studies. Antigen-dependent BCR signaling is involved in several downstream pathways, including NF-kB pathway and PI3K/AKT/mTOR pathway, which can promote B cell survival. BTK inhibitors can jointly inhibit the survival of tumor cells by promoting apoptosis and inhibiting the proliferation of tumor cells, reducing the adhesion of tumor cells, and inhibiting chemokines to prevent the migration of B cells. In this study, BTKi (Ibrutinib) combined with Anti-CD19 CAR-T cells were proposed to treat RR B-NHL, with the main purpose of observing the efficacy and safety of this regimen in patients with relapsed and refractory B-NHL. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05744037
Study type Interventional
Source The Affiliated Hospital of Xuzhou Medical University
Contact
Status Recruiting
Phase Phase 2
Start date January 1, 2023
Completion date January 1, 2025
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