10
Participants
Start Date
December 19, 2024
Primary Completion Date
November 20, 2026
Study Completion Date
December 30, 2026
anti CD19 CAR NK cells
Ten eligible patients with relapsed Acute Lymphoblastic Leukemia will be enrolled based on inclusion criteria and informed consent. After conditioning with Fludarabine and Cyclophosphamide, patients will receive a single infusion of anti-CD19 CAR NK cells with close monitoring using one of the following dose levels: • Dose Level 1: 1×10\^7/Kg • Dose Level 2: 5×10\^7/Kg • Dose Level 3: 1×10\^8/Kg Safety Assessment: Adverse events will be recorded and graded. Laboratory parameters and cytokine release syndrome (CRS) markers will be closely monitored. Efficacy Evaluation: Response assessments will follow International Lymphoma Party (LWP) Group guidelines, including complete response (CR), partial response (PR), stable disease (SD), and progressive disease.
Shahid Ghazi Hospital, Tabriz university of medical sciences, Tabriz
Shahid Beheshti University of Medical Sciences
OTHER