AVC-201-01 is a multicenter, open-label, Phase I study evaluating Allo-RevCAR01-T cells in combination with the CD123 target module (R-TM123) for CD123-positive hematologic malignancies. The innovative RevCAR system allows for pharmacological control of CAR-T cell activity via the administered target module. The primary objective is to evaluate safety and determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). Eligible participants include adult patients with recurrent or refractory acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN), or myelodysplastic syndromes (MDS). CD123 expression is confirmed during screening. Following lymphodepletion, patients receive allogeneic RevCAR-T cells and sequential infusions of R-TM123. Key secondary endpoints include the pharmacokinetics of the T cells and the target module, as well as preliminary anti-leukemic activity.
The AVC-201-01 study is a Phase I first-in-human clinical trial evaluating a controllable form of CAR-T cell therapy for specific types of blood cancer. This approach uses genetically modified immune cells from healthy donors (allogeneic), which are activated only through the additional administration of a special "target module" (R-TM123) to attack cancer cells carrying the CD123 marker. The primary goal of the study is to assess the safety and tolerability of this novel treatment and to determine the appropriate dosage. Eligible participants are adults with advanced acute myeloid leukemia or other malignant blood disorders that have returned or did not respond to previous treatments. Laboratory tests will confirm that the cancer cells carry the required target marker before enrollment. Participants will undergo preparatory chemotherapy followed by infusions of the immune cells and the activating module.
