Engineered immune cells take on tough leukemia in new trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Age: Patients must be ≥18 years old. Diagnosis: Confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) as per the World Health Organization (WHO) criteria. Prior Treatment: Must have failed at least one prior line of chemotherapy or targeted therapy. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Adequate Organ Function: Hematologic function: Absolute neutrophil count (ANC) ≥ 1,000/μL, platelet count ≥ 50,000/μL, and hemoglobin ≥ 8 g/dL (without transfusion support). Renal function: Serum creatinine ≤ 1.5 x upper limit of normal (ULN). Liver function: Total bilirubin ≤ 2 x ULN, AST/ALT ≤ 2.5 x ULN. Informed Consent: The patient must be willing and able to provide written informed consent to participate in the study. Eligible for Apheresis: Patients must be able to undergo the apheresis procedure to collect T cells for CAR-T cell modification. Exclusion Criteria: Active Central Nervous System (CNS) Leukemia: Presence of active leukemia in the CNS. Pregnancy or Breastfeeding: Female patients who are pregnant or breastfeeding. Severe Active Infections: Active and uncontrolled infections, including HIV, hepatitis B or C, or any other severe systemic infections. Other Malignancies: History of another malignancy (except for treated, localized cancers such as basal cell carcinoma) within the past 5 years. Autoimmune Diseases: Active autoimmune diseases requiring systemic immunosuppressive therapy. History of Severe Cytokine Release Syndrome (CRS): Any history of severe CRS or neurological toxicity following prior CAR-T cell therapy. Allergy to Apheresis or CAR-T Cell Components: Known hypersensitivity to any of the components involved in the apheresis or CAR-T cell therapy procedure. Uncontrolled Systemic Disease: Uncontrolled comorbid conditions, such as severe cardiovascular disease, uncontrolled hypertension, or severe pulmonary conditions. Concurrent Participation in Another Clinical Trial: Participation in another clinical trial for AML or related conditions that may interfere with this study's treatment and outcomes. Inability to Comply: Inability to comply with study procedures or follow-up requirements as per the investigator's judgment.