NCT06307054

CLL-1 CAR-NK Cells for Relapsed/Refractory AML

The Safety and Efficacy for Anti-human CLL-1 CAR-NK Cells in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, dose-escalation clinical trial aimed at exploring the safety, tolerability, and pharmacokinetic characteristics of the CLL-1 CAR NK cells, as well as providing preliminary observations on its efficacy in subjects with relapsed/refractory acute myeloid leukemia.

Conditions

• Relapsed Adult AML
• Refractory AML

Interventions

Type	Name	Description
DRUG	anti-CLL-1 CAR NK cells	Eligible patients enrolled in the study after screening will receive lymphocyte collection(from the patient or a donor ) and receive single dose CLL-1 CAR NK cells infusion after a successful cell production. There are a total of four cell dose level:5×10\^6 CAR-NK cells/kg,1×10\^7CAR-NK cells/kg,2×10\^7CAR-NK cells/kg,4×10\^7CAR-NK cells/kg

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-03-15
• Completion: 2027-03-15
• First posted: 2024-03-12
• Last updated: 2025-09-30

Locations

1 site across 1 country: China