Cell Therapy with Anti-CD19 CAR-NK Cells in Patients with Relapsed or Resistant B-ALL

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 19, 2024

Primary Completion Date

November 20, 2026

Study Completion Date

December 30, 2026

Conditions
Acute Lymphocytic Leukemia in Relapse
Interventions
BIOLOGICAL

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.

Trial Locations (1)

Unknown

Shahid Ghazi Hospital, Tabriz university of medical sciences, Tabriz

All Listed Sponsors
lead

Shahid Beheshti University of Medical Sciences

OTHER

NCT06631040 - Cell Therapy with Anti-CD19 CAR-NK Cells in Patients with Relapsed or Resistant B-ALL | Biotech Hunter | Biotech Hunter