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

Korábbi kezelés

• Previously received any form of gene therapy.
• 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.

Más betegség

• Presence of uncontrolled fungal, bacterial, treponemal (e.g., syphilis), viral, or other infections.
• Active hepatitis B (Hepatitis B virus DNA > 500 IU/mL) or a positive Hepatitis C virus RNA (HCV-RNA) test.
• Human Immunodeficiency Virus (HIV) infection, or syphilis infection.
• The patient has an allergic constitution or is allergic to macromolecular biologics such as antibodies or cytokines.
• 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.
• Uncontrolled psychiatric illness.
• A history of drug abuse/addiction.

Egyéb

• The patient will be excluded if meeting any of the following criteria:
• Women who are pregnant or breastfeeding.

• The patient or their legal guardian voluntarily participates and has signed the informed consent form.
• 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:
• . 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.
• . Ineligible for bone marrow transplantation, or have undergone bone marrow transplantation but failed to achieve long-term remission.
• Expression of both CLL-1 and CD70 targets is confirmed as positive by flow cytometry.
• Patients must have good major organ function:
• . Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol/L.
• . Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL/min.
• . Lung function: Oxygen saturation ≥ 95%, with no active pulmonary infection.
• . Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; no significant pericardial effusion, and no clinically significant ECG abnormalities.
• 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.
• 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.