NCT07263906 Clinical Study of LILRA6 CAR-T for the Treatment of R/R Acute Myeloid Leukemia
| NCT ID | NCT07263906 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Refractory Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2025-12-01 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily participate in this study and sign the informed consent form. 2. Age range: 18 - 75 years old. Gender is not restricted. 3. 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). 4. Expected survival period ≥ 12 weeks. 5. The positive rate of LILRA6 expression in bone marrow/tumor cells is ≥ 20% 6. ECOG score ranging from 0 to 2 points. 7. 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. 8. Allow those who have previously undergone a single autologous hematopoietic stem cell transplantationAllowing previous recipients of a single autologous hematopoietic stem cell transplantation. 9. 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. 10. There are no uncontrollable infectious activities (including lung infections). 11. Distance from the last anti-tumor treatment: Systemic chemotherapy / systemic radiotherapy / immunotherapy ≥ 3 weeks, targeted drug elution period ≥ 2 weeks. 12. No active infection of the novel coronavirus or influenza. Exclusion Criteria: 1. Those who have a severe history of allergic reaction to any component of the cell preparation or the pre-treatment chemotherapy drugs. 2. Those with a history of other active malignant tumors. 3. 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. 4. 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). 5. According to the New York Heart Association (NYHA) classification of cardiac function, those with cardiac function at grade III or IV. 6. 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. 7. 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.
Contact & Investigator
Wenbin Qian, Professor
STUDY CHAIR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT07263906 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Refractory Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07263906 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07263906 currently recruiting?
Yes, NCT07263906 is actively recruiting participants. Contact the research team at qianwb@zju.edu.cn for enrollment information.
Where is the NCT07263906 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07263906 clinical trial?
NCT07263906 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Wenbin Qian, Professor at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 48 participants.
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