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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
lentiviral vector-transducted peripheral blood-derived T cells to express anti-LILRA6 CAR
The Second Affiliated Hospital,School of Medicine,Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGIncidence of dose limiting toxicity (DLTs)
To evaluate the safety, tolerability, and determine the recommended dosage of peripheral blood-derived Anti-LILRA6 CAR-T Cell Therapy for refractory/relapsed peripheral T-cell lymphoma.
Time frame: Up to 28 days
Complete response rate (CR)
To determine the anti-tumor effectivity of PB LILRA6 CAR-T
Time frame: 3 months
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