Engineered immune cells take on tough leukemia in early trial
NCT ID NCT07263906
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new type of immune cell therapy called LILRA6 CAR-T for people with acute myeloid leukemia that has come back or not responded to standard treatment. The therapy uses a patient's own T cells, modified in a lab to target leukemia cells. The study will enroll 48 participants to check safety and see if the treatment can shrink the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LILRA6 CAR-T cells (engineered immune cells)
- What this could lead to
- If it works, this could point toward a new treatment option for people with hard-to-treat acute myeloid leukemia.
- What could go wrong
- This is a very early Phase 1 trial with only 48 people, so it may not work or could have unexpected side effects. CAR-T therapy can cause severe immune reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second Affiliated Hospital,School of Medicine,Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310009, China
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- Gentler chemo approach shows promise for tough blood cancers in older patients
- Selective immune cell removal may tame transplant complications
- Promising combo for IDH1 leukemia hits early snag – trial stopped