NCT07263906

Clinical Study of LILRA6 CAR-T for the Treatment of R/R Acute Myeloid Leukemia

Dose Escalation and Expansion Clinical Study of Targeted LILRA6 CAR-T for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and efficacy of LILRA6-directed chimeric antigen receptor T cells (LILRA6 CAR-T cells) in patients with refractory or relapsed acute myeloid leukemia(AML).

Detailed description

This is a single-center, open-label, single-arm, dose-escalation and dose-expansion phase I clinical trial designed to evaluate the safety and preliminary efficacy of LILRA6-targeted CAR-T cell therapy in patients with relapsed or refractory acute myeloid leukemia (AML) expressing LILRA6. Phase I (Dose Escalation) The dose-escalation phase will follow a conventional 3+3 design, with a single dose level administered via intravenous infusion. Each cohort will include 3 to 6 patients. Following the initial infusion, patients will be monitored for at least 28 days to assess safety, and subsequently followed for up to 2 years to evaluate long-term outcomes. Phase II (Dose Expansion) Based on the safety profile, persistence of LILRA6 CAR-T cells, and preliminary efficacy results observed in Phase I, the recommended dose and administration schedule will be established. Approximately 30 eligible patients will then be enrolled in the dose-expansion phase to further assess the safety and efficacy of LILRA6 CAR-T cell therapy at the selected dose. After the first infusion, all patients will continue in long-term follow-up for up to 2 years post-treatment.

Conditions

• Refractory Acute Myeloid Leukemia
• Recurrent Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Anti-LILRA6 CAR-T cells	lentiviral vector-transducted peripheral blood-derived T cells to express anti-LILRA6 CAR

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: China