Safety and Efficacy of Anti-FLT3 CAR- T Cell (TAA05 Cell Injection) in the Treatment of Relapsed/ Refractory Acute Myeloid Leukemia
This is a clinical trial of Anti-FLT3 CAR-T Cell (TAA05 Cell Injection) in the treatment of patients with relapsed / refractory acute myeloid leukemia. The purpose is to evaluate the safety and efficacy of anti-FLT3 CAR-T cells in patients with relapsed / refractory acute myeloid leukemia.
⁃ Aged 18 \
• 70 years old (including boundary value), regardless of gender;
⁃ FLT-3 positive acute myeloid leukemia;
⁃ The expected survival time was more than 3 months;
⁃ ECOG score 0-2;
⁃ Refractory or relapsed AML patients after standardized treatment who meet any of the following criteria:
∙ After complete remission (CR), there were ≥5% leukemia cells or blast cells in the bone marrow(except for other reasons such as bone marrow regeneration after consolidation chemotherapy)in the peripheral blood and extramedullary lesions;
‣ Naive patients who are treated with 2 courses of treatment and are ineffective;
‣ Those who have relapsed within 12 months after CR after consolidation and intensive treatment;
‣ Those who relapse after 12 months but are ineffective after conventional chemotherapy;
‣ Subjects who experienced relapses twice or multiple times; with persistent extramedullary leukemia.
⁃ Kidney function, cardiopulmonary function, liver function, and coagulation function meet the following requirements:
∙ Creatinine ≤ 1.5 ULN;
‣ Left ventricular ejection fraction ≥ 50% and echocardiography does not reveal pericardial effusions and ECG does not reveal clinically significant abnormal bands;
‣ Blood oxygen saturation \> 92%;
‣ Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; for the patients with ALT and AST abnormalities caused by disease which researchers judge (e.g. liver infiltrates or bile duct obstruction), the indicators of which can be relaxed to ≤5× ULN;
‣ PT/INR and PTT ≤ 1.5 ULN;
⁃ Patients understand the trial and have signed the informed consent form.