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

NCT07263906 | Recruiting Phase 1

• 1 other identifier: 2025-1003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia

Keywords

Refractory/recurrent acute myeloid leukemia; LILRA6 CAR-T; Acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• Incidence 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.

  Up to 28 days

Secondary Outcomes (1)

• Complete response rate (CR)

  3 months

Other Outcomes (4)

• Overall response rate (ORR)

  3 months

• Progression free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

PB LILRA6 CAR-T

EXPERIMENTAL

Biological: Anti-LILRA6 CAR-T cells

Interventions

Anti-LILRA6 CAR-T cells BIOLOGICAL

lentiviral vector-transducted peripheral blood-derived T cells to express anti-LILRA6 CAR

PB LILRA6 CAR-T

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this study and sign the informed consent form.
• Age range: 18 - 75 years old. Gender is not restricted.
• Refractory/Recurrent AML: Meeting any one of the following criteria for refractory or recurrent cases is sufficient. 1) Refractory: (1) In the case of a newly diagnosed patient, treatment with the standard regimen for two courses fails to achieve complete remission (CR); (2) Recurrence within 12 months after consolidation and intensification therapy following CR; (3) Recurrence after 12 months with no response to salvage chemotherapy; (4) ≥ 2 recurrences; (5) Persistent extramedullary leukemia; 2) Recurrence: (1) Leukemia cells reappear in the peripheral blood after complete remission (CR) of AML; (2) The percentage of blasts in the bone marrow is ≥ 5% (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy); (3) Infiltration of leukemia cells in sites other than the bone marrow (excluding the central nervous system).
• Expected survival period ≥ 12 weeks.
• The positive rate of LILRA6 expression in bone marrow/tumor cells is ≥ 20%
• ECOG score ranging from 0 to 2 points.
• Sufficient organ function reserve: Alanine aminotransferase and Aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value); Creatinine clearance rate (Cockcroft-Gault method) ≥ 45 mL/min; Serum total bilirubin ≤ 1.5× UNL; Ejection fraction of the heart (EF) ≥ 45%; In an indoor natural air environment, baseline oxygen saturation \> 92%; Blood routine: All of the following criteria are met: Absolute number of neutrophils ≥ 0.5×10\^9 /L, Platelet count ≥ 30×10\^9 /L, Hemoglobin ≥ 7.0 g/dl.
• Allow those who have previously undergone a single autologous hematopoietic stem cell transplantationAllowing previous recipients of a single autologous hematopoietic stem cell transplantation.
• Pregnancy tests for the female subjects of childbearing age must be negative, and they must also agree to take effective contraceptive measures during the trial.
• There are no uncontrollable infectious activities (including lung infections).
• Distance from the last anti-tumor treatment: Systemic chemotherapy / systemic radiotherapy / immunotherapy ≥ 3 weeks, targeted drug elution period ≥ 2 weeks.
• No active infection of the novel coronavirus or influenza.

You may not qualify if:

• Those who have a severe history of allergic reaction to any component of the cell preparation or the pre-treatment chemotherapy drugs.
• Those with a history of other active malignant tumors.
• There are active infections that require treatment (excluding simple urinary tract infections and bacterial pharyngitis); the use of prophylactic antibiotics, antiviral drugs, and antifungal drugs is permitted.
• Active hepatitis B (with HBsAg positive and HBV-DNA ≥ 10³ copies/mL), hepatitis C infection, syphilis, or other acquired/innate immune deficiency disorders (including HIV infection).
• According to the New York Heart Association (NYHA) classification of cardiac function, those with cardiac function at grade III or IV.
• Previous anti-tumor treatment-related toxic reactions have not yet recovered to a grade ≤ 1 (according to CTCAE 5.0), except for fatigue, anorexia and hair loss.
• Those with a history of epilepsy or other central nervous system diseases that may affect the research assessment.
• : Those who have received any other targeted LILRA6 drug treatment before. 9.Breastfeeding women who do not wish to stop breastfeeding. 10.The researchers believe that there may be any other circumstances that could increase the risks for the subjects or interfere with the test results.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital,School of Medicine,Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Wenbin Qian, Professor

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Wenbin Qian, Professor

CONTACT

13605801032; qianwb@zju.edu.cn

Wen Lei, Doctor

CONTACT

18258448016; leiwen2017@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)