acute myeloid leukemia
Conditions
Interventions
Treatment:infusion of CAR-T
Sponsors
Guangdong Second Provincial General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) All subjects or legal guardians must sign the informed consent approved by the ERC in person before starting any screening procedure; 2) Patients with acute myeloid leukemia aged > 18 years; 3) For acute myeloid leukemia (AML) diagnosed as CLL1 antigen marker positive, relapse during chemotherapy, or primary drug resistance, or hematologic relapse after drug withdrawal, complete hematologic remission cannot be achieved after 1 course of chemotherapy (standard reference: NCCN,2015.2); 4) ECOG physical fitness level = 2 (see Appendix 2); 5) The main tissues and organs of the patients have good functions: (1) Liver function: ALT/AST < 3 times the upper limit of normal value (ULN) and bilirubin =34.2µmol/L; (2) Renal function: creatinine < 220µmol/L; (3) Lung function: indoor oxygen saturation =95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) =45%; 6) Fertile women must comply with the following requirements: Subjects must agree to use a highly effective contraceptive method and agree to continue using a highly effective contraceptive method for at least 100 days from signing the informed consent to receiving the infusion; 7) The venous access required for collection can be established, without contraindications for leukocyte collection; 8) Willing and able to follow the taboos and restrictions stipulated in the program.
Exclusion criteria
Exclusion criteria: 1) Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment; 2) Hepatitis B/C virus; 3) Human immunodeficiency virus (HIV) seropositive; 4) Have a history of primary tumors other than acute myeloid leukemia; 5) Suffering from severe autoimmune diseases or immunodeficiency diseases; 6) The patient is allergic to large molecular biological drugs such as antibodies or cytokines; 7) Present with the following heart conditions: New York heart association(NYHA) Stage III or IV congestive heart failure; Had myocardial infarction or received coronary artery bypass graft (CABG) =6 months before enrollment; A history of clinically significant ventricular arrhythmias, or unexplained syncope, non-vasovagal or not due to dehydration; A history of severe non-ischemic cardiomyopathy; Assessment by echocardiography or multiplex circuit detection (MUGA) scan (=8 weeks before monotherapy) , Impaired cardiac function (LVEF < 45%);; 8) Any issues that are not conducive to the subject's acceptance or tolerance of planned treatment at the study center, understanding of informed consent, or any condition that the investigator considers is not in the subject's best interest (e.g. harmful to health) to participate in the study, or any condition that may prevent, limit, or confuse the evaluation prescribed in the study protocol; 9) Pregnant or lactating women; 10) Patients whom the investigator considered excluded from the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactQing Zhang
Guangdong Second Provincial General Hospital
Outcome results
None listed