Relapsed B-cell Acute Lymphoblastic Leukemia After CD19 CAR-T ACI Clinical Trial
Official title:
Phase I/II Study to Evaluate Treatment of Relapsed B-cell Acute Lymphoblastic Leukemia After CD19 CAR-T Adoptive Cellular Immunotherapy With CAR-T Cells Targeting CD38
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. CD38 CAR-T cells can recognize and kill the CD19 negative malignant cells through recognition of CD38. This is a phase 1/2 study designed to determine the safety of the gene-edited specificity CD38 CAR-T cells and the feasibility of making enough to treat patients with relapsed B-cell acute lymphoblastic leukemia after CD19 CAR-T adoptive cellular immunotherapy.
1. PRIMARY OBJECTIVES:
1. To evaluate the feasibility and safety of specificity CD38 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 CD38 CAR-T cells over
time.
2. SECONDARY OBJECTIVES:
1. For patients with detectable disease, measure anti-tumor response due to
specificity CD38 CAR-T cell infusions.
2. The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a
using Day 0: 1-5x10e6/kg total dose on day 0.
;