TAA05 Injection in the Treatment of Adult Patients With FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia

• Aged 18 to 70 years old (inclusive), male or female;
• Expected survival time ≥ 3 months;
• ECOG performance status of 0-2;
• A clear diagnosis of acute myeloid leukemia at screening and positive expression of FLT3 in tumor cells;

• Subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment and meet any of the following criteria:

  1. After AML complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration;
  2. Initial cases that failed after 2 courses of standard treatment;
  3. After CR, patients with relapse within 12 months after consolidation and intensive treatment;
  4. Patients who relapsed after 12 months but did not respond to conventional chemotherapy;
  5. 2 or more relapses; persistent extramedullary leukemia;

• Coagulation function, liver and kidney function, cardiopulmonary function meet the following requirements:

  1. Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time≤1.5 ULN;
  2. Creatinine≤1.5 ULN;
  3. Left ventricular ejection fraction≥50%, and no pericardial effusion was found on echocardiography, and no clinically significant abnormal bands were found on electrocardiography;
  4. Indoor baseline oxygen saturation>92%;
  5. Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; for ALT and AST abnormalities due to disease (e.g., liver infiltration or bile duct obstruction) as judged by the investigator, the indicators can be relaxed to ≤ 5 × ULN;
• Patients who can understand the trial and have signed informed consents.

Exclusion Criteria:

• Subjects with malignant tumors other than acute myeloid leukemia within 5 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical mastectomy;
• Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA test; positive for syphilis test;
• Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia;
• Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;
• Within 7 days prior to screening, there are active or uncontrollable infections requiring systemic therapy (except for mild genitourinary infection and upper respiratory tract infection);
• Pregnant or lactating women, and female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after cell infusion;
• Subjects who are receiving systemic steroid therapy within 7 days prior to screening or need long-term use of systemic steroid therapy during treatment as judged by the investigator (except for inhalation or topical use);
• Subjects who have participated in other clinical studies within 1 months prior to screening;
• Subjects who have evidence of central nervous system invasion at screening, such as tumor cells detected in cerebrospinal fluid or imaging suggesting central infiltration;
• Patients with graft-versus-host reaction and need to use immunosuppressants;
• Patients with a history of epilepsy or other central nervous system diseases;
• Patients with primary immunodeficiency disease;
• Conditions not eligible for cell preparation as judged by the investigator;
• Other conditions considered unsuitable for enrollment by the investigator.