Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT07263906
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of LILRA6 CAR-T for the Treatment of R/R Acute Myeloid Leukemia
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official Title:
Dose Escalation and Expansion Clinical Study of Targeted LILRA6 CAR-T for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: