Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory/Relapsed AML

Inclusion Criteria:

1\. The patient or their legal guardian voluntarily participates and has signed the informed consent form.

2\. Age between 18 and 75 years old (inclusive), with no gender restrictions. 3. Diagnosed as having refractory/relapsed acute myeloid leukemia, meeting one of the following criteria:

1. . Reappearance of leukemic cells in peripheral blood after achieving complete remission, or bone marrow blast count \> 5% (excluding other causes such as bone marrow reconstitution post-consolidation chemotherapy), or the presence of extramedullary leukemic cell infiltration.
2. . Ineligible for bone marrow transplantation, or have undergone bone marrow transplantation but failed to achieve long-term remission.

4\. Expression of both CLL-1 and CD70 targets is confirmed as positive by flow cytometry.

5\. Patients must have good major organ function:

1. . Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol/L.
2. . Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL/min.
3. . Lung function: Oxygen saturation ≥ 95%, with no active pulmonary infection.
4. . Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; no significant pericardial effusion, and no clinically significant ECG abnormalities.

6\. Women of childbearing age must have a negative urine/blood pregnancy test during screening and agree to use contraceptive measures for at least 1 year after infusion. Male subjects with reproductive capacity must agree to use effective barrier contraception for at least 1 year after infusion.

7\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. 8. Expected life expectancy greater than 3 months. 9. The patient is willing to cooperate with the collection of peripheral blood mononuclear cells, medical examinations, and regular follow-up visits.

Exclusion Criteria:

The patient will be excluded if meeting any of the following criteria:

1. Women who are pregnant or breastfeeding.
2. Presence of uncontrolled fungal, bacterial, treponemal (e.g., syphilis), viral, or other infections.
3. Active hepatitis B (Hepatitis B virus DNA \> 500 IU/mL) or a positive Hepatitis C virus RNA (HCV-RNA) test.
4. Human Immunodeficiency Virus (HIV) infection, or syphilis infection.
5. Previously received any form of gene therapy.
6. The patient has an allergic constitution or is allergic to macromolecular biologics such as antibodies or cytokines.
7. History of clinically significant central nervous system diseases, such as: epilepsy, hemiparesis, aphasia, stroke, severe brain trauma, dementia, Parkinson's disease, cerebellar diseases, or organic brain syndromes.
8. Uncontrolled psychiatric illness.
9. A history of drug abuse/addiction.
10. Use of prohibited medications:

(1). Hormones: Use of corticosteroids (prednisone ≥ 2 mg/kg or equivalent \> 20 mg/day) within 2 weeks prior to cell collection. Recent or ongoing use of inhaled, topical, or non-absorbable steroids is not an exclusion criterion.

(2). Radiotherapy/Chemotherapy:Receipt of radiotherapy or salvage chemotherapy for the study disease within 3 weeks prior to cell collection.

(3). Use of immunosuppressive agents within 4 weeks prior to cell collection. (4). Participation in another clinical trial or receipt of a major non-diagnostic surgical procedure within 4 weeks prior to cell collection.

(5). Use of alemtuzumab within 6 months, or cladribine/clofarabine within 3 months, prior to cell collection.