Tests LILRA6 CAR-T cells in adults with relapsed or refractory acute myeloid leukemia
Tests modified immune cells targeting LILRA6 in adults with returning or treatment-resistant leukemia.
Plain-language title generated from the registry record
Registry title: Clinical Study of LILRA6 CAR-T for the Treatment of R/R Acute Myeloid Leukemia
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute myeloid leukemia (AML) that did not respond to treatment or came back, and whose leukemia cells carry the LILRA6 marker.
- Age
- 18 to 75 years
- Sex
- Women and men can join.
- Disease stage
- Refractory or relapsed AML. Expected survival of at least 12 weeks and ECOG score of 0 to 2.
- Earlier treatment
- At least 3 weeks since the last systemic chemotherapy, systemic radiotherapy or immunotherapy. At least 2 weeks since the last targeted drug. A single earlier autologous stem cell transplant is allowed. Earlier treatment with another LILRA6-targeted drug is not allowed.
- Biomarker or test result
- LILRA6 must be found on 20% or more of the bone marrow or tumor cells.
Main reasons for not taking part
- Severe allergy to the cell product or the chemotherapy drugs used before it
- Another active cancer
- Active infection that needs treatment, active hepatitis B, hepatitis C, syphilis or HIV infection
- Heart function grade III or IV (NYHA)
- History of epilepsy or other brain or nerve disease that could affect the study
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07263906, who can take part
Where in China
- The Second Affiliated Hospital,School of Medicine,Zhejiang UniversityHangzhou, ChinaContact: Wenbin Qian, ProfessorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07263906
- Record updated
- 4 December 2025
- Original description
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).Read full original descriptionShow less
Dose Escalation and Expansion Clinical Study of Targeted LILRA6 CAR-T for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
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).
Inclusion: 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.
Exclusion: 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; 8: 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; 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.