This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U32 injection in patients with acute myeloid leukemia.
Voluntarily sign the informed consent form and be expected to complete the follow-up examinations and treatments as required by the study protocol.
Be aged ≥2 years and ≤65 years at the time of signing the informed consent form, with no restrictions on gender.
Meet the AML diagnosis according to the 2022 WHO classification and satisfy the diagnostic criteria for relapsed and refractory acute myeloid leukemia as defined in the "Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2023 Edition)": a) Relapsed AML diagnostic criteria: reappearance of leukemia cells in peripheral blood after complete remission (CR), or positivity for minimal residual disease (MRD) detected by flow cytometry in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration of leukemia cells. b) Refractory AML diagnostic criteria: newly diagnosed cases that are ineffective after two courses of standard treatment; relapse within 12 months after CR and subsequent consolidation therapy; relapse after 12 months that is ineffective to conventional chemotherapy; cases with two or more relapses; persistent extramedullary leukemia.
AML patients who are molecularly positive after treatment and cannot achieve negativity through conventional therapy.
Having other malignancies within 3 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.
Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with detectable HBV-DNA levels above the lower limit of detection in peripheral blood; positive for hepatitis C virus (HCV) antibodies with detectable HCV-RNA levels above the lower limit of detection; positive for human immunodeficiency virus (HIV) antibodies; positive for cytomegalovirus (CMV) DNA; positive for EBV-DNA; positive for syphilis serology.
A history of severe allergic reactions [defined as allergic reactions of grade 2 or higher, with any of the following clinical manifestations: airway obstruction (rhinorrhea, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), urinary or fecal incontinence, laryngeal edema, bronchial spasm, cyanosis, shock, respiratory or cardiac arrest] or known allergy to any active ingredient, excipient, or murine product or xenoprotein contained in the study drug (including the lymphodepletion regimen).
Severe cardiac disease, including but not limited to severe arrhythmias, unstable angina, large myocardial infarction, New York Heart Association (NYHA) Class III or IV heart failure, refractory hypertension (defined as failure to achieve target blood pressure despite the use of a reasonable and tolerable regimen of ≥3 antihypertensive medications [including diuretics] for >1 month or requiring ≥4 antihypertensive medications for effective blood pressure control).
Single group
U32 CAR-T
DrugLymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.
Incidence of Adverse events after U32CAR-T cells infusion [Safety and Tolerability]
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Pharmacokinetics of U32 CAR-T cells
Time at the maximal concentration(Tmax)
Pharmacokinetics of U32 CAR-T cells
Area under the concentration-time curve(AUC)
Pharmacokinetics of U32 CAR-T cells
The maximal concentration of eripheral blood (Cmax)
Pharmacodynamics of U32 CAR-T cells
Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, ferritin and CRP at each time point
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