EMA Gives AvenCell Permission to Start CD123-Directed CAR T-Cell Therapy Study
AvenCell Therapeutics on Tuesday said the European Medicines Agency has approved its clinical trial application to study the allogeneic CAR T-cell therapy AVC-201 in CD123-positive hematologic malignancies.
The agency's decision has cleared the way for Cambridge, Massachusetts-based AvenCell to begin a Phase I trial involving up to 35 patients with CD123-positive acute myeloid leukemia at multiple sites in Germany. In the trial, researchers will assess the safety of AvenCell's CD123-directed AVC-201 and establish its maximum tolerated dose. CD123 is overexpressed in around 80 percent of acute myeloid leukemia cases, as well as in some other hematologic malignancies.
AVC-201 comprises a cellular component (Allo-RevCAR01-T) and a recombinant antibody derivative (R-TM123), which form the active drug when combined. R-TM123 functions as a bridge between Allo-RevCAR01-T and the CD123 epitope on the cancer cell.
Patients in the Phase I trial will receive a continuous infusion of R-TM123 recombinant antibody derivative following lymphodepleting therapy from the first to the 20th day of treatment. After four hours of infusion, a single dose of Allo-RevCAR01-T cellular component will be given intravenously. In addition to determining the treatment's safety, dose-limiting toxicities, and maximum tolerated dose, researchers will also measure its efficacy by tracking complete remission, overall response rate, progression-free survival, and overall survival in patients.
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