NCT06690827

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

Clinical Study of CD123 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse/refractory Acute Myeloid Leukemia (AML)or Blastic Plasmacytoid Dendritic Cell Neoplasm(BPDCN)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD123 CAR-NK in the treatment of patients with relapsed/refractory acute myeloid leukemia or blastic plasma cell like dendritic cell tumors.

Detailed description

This study is a single-arm, open-label, dose-finding and expansion clinical trial aimed at evaluating the safety and efficacy of antiCD123 CAR-NK therapy for the treatment of patients with relapsed/refractory AML or BPDCN. The goal is to determine the recommended dose of CAR-NK cell therapy for these conditions. The study includes three dose groups: 1×107 CAR-positive cells/kg, 3×107 CAR-positive cells/kg, and 5×107 CAR-positive cells/kg. Each patient will receive two infusions of CAR-NK cells on D0 and D7, respectively, with the doses for both infusions principally remaining the same. However, the investigaors have the flexibility to adjust the second infusion dose based on the subject's condition.

Conditions

• AML (Acute Myeloid Leukemia)
• BPDCN (blastic Plasmacytoid Dendritic Cell Neoplasm)

Interventions

Type	Name	Description
DRUG	Anti-CD123 CAR NK cells	Each patient will receive two CAR-NK cell infusions at D0 and D7, and CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion.

Timeline

• Start date: 2024-11-13
• Primary completion: 2027-10-30
• Completion: 2028-10-30
• First posted: 2024-11-15
• Last updated: 2024-11-15

Locations

1 site across 1 country: China