Study of CD123-Targeted CAR-NK Cell Therapy for Adults with Relapsed or Refractory Acute Myeloid Leukemia or BPDCN

What this Trial Is About

Researchers are studying the safety and effectiveness of anti-CD123 CAR-NK cell therapy for patients with relapsed or refractory acute myeloid leukemia AML or blastic plasmacytoid dendritic cell neoplasm BPDCN. This phase 1, single-arm, open-label trial aims to find the best dose of this cell therapy for these difficult-to-treat conditions. The study focuses on patients whose tumor cells express the CD123 marker and who have limited treatment options due to relapse or resistance to standard therapies. Participants will receive two infusions of anti-CD123 CAR-NK cells, given seven days apart. The study includes three dosage groups 1x107, 3x107, and 5x107 CAR-positive cells per kilogram of body weight. The dose for the second infusion may be adjusted based on each patients condition, and the cells must be infused within 70 minutes after thawing. This dose-finding approach helps determine the recommended treatment level for future use. During the trial, patients will be closely monitored for safety and treatment response. Researchers will track side effects occurring within 28 days and measure responses such as complete or partial remission over the first three months. Long-term outcomes including overall survival, duration of response, recurrence-free survival, and event-free survival will be followed for up to two years. Various laboratory tests, imaging, and clinical assessments will be conducted to evaluate the therapys impact and patients health throughout the study period.

Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/refractory AML or BPDCN