TAA05 Cell Injection in the Treatment of Recurrent / Refractory Acute Myeloid Leukemia

This is an interventional treatment trial for CAR Read More

Inclusion Criteria:

1. Age 18 ~ 70 years old (including boundary value), regardless of gender;
2. Acute myeloid leukemia with FLT3 positive (positive rate ≥ 30%) verified by flow cytometry or immunohistochemistry;
3. The expected survival time was more than 12 weeks;
4. ECoG score 0-2;
5. Refractory or relapse after standardized treatment;

6. Liver and kidney function and cardiopulmonary function meet the following requirements:

   1. Creatinine ≤ 1.5 ULN;
   2. Left ventricular ejection fraction ≥ 45%;
   3. Blood oxygen saturation > 91%;
   4. Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN；
7. Understand the test and have signed the informed consent form.

Exclusion Criteria:

1. Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive agents;
2. Malignant tumors other than acute myeloid leukemia within 5 years before screening, except fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and breast ductal carcinoma in situ after radical operation;
3. hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference range; Hepatitis C virus (HCV) antibody positive and hepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis test positive;
4. Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ grade III), severe arrhythmia;
5. Unstable systemic diseases judged by the researcher: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
6. Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);
7. Pregnant or lactating women, female subjects who planned pregnancy within 1 year after cell reinfusion, or male subjects whose partners planned pregnancy within 1 year after cell reinfusion;
8. Those who had received car-t therapy or other gene modified cell therapy before screening;
9. Subjects who were receiving systemic steroid treatment within 7 days before screening or who were determined by the investigator to need long-term systemic steroid treatment during treatment (except inhalation or local use);
10. Participated in other clinical studies within 3 months before screening;
11. There was evidence of central nervous system invasion during subject screening;
12. According to the judgment of the researcher, it does not conform to the situation of cell preparation;
13. Other researchers believe that it is not suitable for inclusion.