B Cell Lymphoma Clinical Trial
Official title:
Phase I/II Study to Evaluate Treatment of Relapsed or Refractory Leukemia and Lymphoma With Universal CRISPR-Cas9 Gene-Editing CAR-T Cells Targeting CD19 and CD20 or CD22
CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells. Dual Specificity CD19 and CD20 or CD22 CAR-T cells can recognize and kill the CD19 negative malignant cells through recognition of CD20 or CD22. This is a phase 1/2 study designed to determine the safety of the allogenic gene-edited dual specificity CD19 and CD20 or CD22 CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory hematological malignancies.
1. PRIMARY OBJECTIVES:
1. To evaluate the feasibility and safety of universal dual specificity CD19 and CD20
or CD22 CAR-T cells in patients with relapsed or refractory leukemia and lymphoma.
2. To evaluate the duration of in vivo persistence of adoptively transferred T cells,
and the phenotype of persisting T cells. Real Time polymerase chain receptor
(RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to
detect and quantify survival of universal dual specificity CD19 and CD20 or CD22
CAR-T cells over time.
2. SECONDARY OBJECTIVES:
1. For patients with detectable disease, measure anti-tumor response due to universal
dual specificity CD19 and CD20 or CD22 CAR-T cell infusions.
2. Determine if cellular or humoral host immunity develops against the murine
anti-CD19, and assess correlation with loss of detectable universal dual
specificity CD19 and CD20 or CD22 CAR-T cells (loss of engraftment).
The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using a "split
dose" approach to dosing: 10% on day 0, 30% on day 1 and 60% on day 2.
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