Spots Global Cancer Trial Database for Cord Blood Derived Anti-CD19 CAR-Engineered NK Cells for B Lymphoid Malignancies

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Trial Identification

Brief Title: Cord Blood Derived Anti-CD19 CAR-Engineered NK Cells for B Lymphoid Malignancies

Official Title: Safety and Efficacy of Cord Blood Derived Anti-CD19 CAR-Engineered NK Cells for Relapsed/Refractory B Lymphoid Malignancies: a Single-center, Open-label, Single-arm Clinical Study

Study ID: NCT04796675

Conditions

Acute Lymphocytic Leukemia

Chronic Lymphocytic Leukemia

Non Hodgkin's Lymphoma

Interventions

Fludarabine + Cyclophosphamide + CAR-NK-CD19 Cells

Study Description

Brief Summary: This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of anti-CD19 chimeric antigen receptor(CAR)-modified NK cells(CAR-NK-CD19) in patients with relapsed or refractory hematological malignancies.

Detailed Description: Anti-CD19 chimeric antigen receptor (CAR) T-cell therapy has shown remarkable clinical efficacy in B-cell cancers. However, CAR T cells can induce substantial toxic effects, and the manufacture of the cells is complex. Natural killer (NK) cells that have been modified to express an anti-CD19 CAR have the potential to overcome these limitations. Cord blood(CB) derived NK cells from healthy donor are the source for production of CAR-NK-CD19 cells. CB derived NK cells are purified and transduced with a retroviral vector encoding the anti-CD19 CAR and interleukin-15. This is an investigational study. The objectives are to evaluate the safety and efficacy of CAR-NK-CD19 cells in patients with CD19+ B-cell malignancies.