acute myeloid leukemia
Conditions
Interventions
Treatment group:Inject CAR-T cells
Sponsors
Huizhou Municipal Central Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. All patients or legal guardians must sign the informed consent approved by the Ethics Committee in person before starting any screening process; 2. Patients with acute myeloid leukemia aged > 5 years; 3. Acute myeloid cell leukemia (AML) diagnosed with CLL1/CD33/CD123 antigen labeling positive, relapsed during chemotherapy, or primary drug resistance, or hematologic relapsed after discontinuation of chemotherapy without complete hematologic response for 1 course of chemotherapy (standard reference NCCN,2015.2); 4. ECOG physical status level =95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >=40%; 6. Fertile women must comply with the following requirements: patients must consent to the use of a highly effective contraceptive method and consent to continued use of a highly effective contraceptive method for at least 100 days from the time of signing the ICF and receiving the infusion of this product; 7. Venous access required for collection can be established without contraindications for white blood cell collection; 8. Willingness and ability to comply with the taboos and limitations set out in this programme.
Exclusion criteria
Exclusion criteria: 1. The patient had an uncontrollable infectious disease within 4 weeks prior to enrollment; 2. Hepatitis B/C virus; 3. Human immunodeficiency virus (HIV) seropositivity; 4. Have had primary tumors other than acute myeloid leukemia; 5. Suffering from serious autoimmune diseases or immunodeficiency diseases; 6. The patient is allergic to antibodies, cytokines and other macromolecular biological drugs; 7. The following heart problems occur: (1) New York Heart Association (NYHA) Stage III or IV congestive heart failure; (2) Had myocardial infarction or coronary artery bypass graft (CABG) <=6 months before enrollment; (3) Clinically significant ventricular arrhythmias, or a history of unexplained syncope, non-vasovagal or not due to dehydration; (4) History of severe non-ischemic cardiomyopathy; 8. Any problem that is not conducive to the patient receiving or tolerating the planned treatment at the study Center, understanding the informed consent, or any condition that the investigator believes is not in the patient's best interest (e.g. detrimental to health) to participate in the study, or any condition that may prevent, limit, or confuse the evaluation required by the study protocol; 9. Pregnant or lactating patients; 10. Patients considered ineligible for study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| recurrence free survival rate;event-free survival rate;overall survival; | — |
Countries
China
Contacts
Public ContactLi Guowei
Outcome results
None listed