Acute myeloid leukemia
Conditions
Interventions
Experimental group:14/5000 Single, intravenous infusion of CAR T cells
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. All subjects or legal guardians must sign in person a letter approved by the IRB prior to the commencement of any screening process informed consent; 2. Patients with acute myeloid leukemia aged > 5 years; 3. diagnosed CLL1 antigen positive acute myeloid leukemia (AML), relapse during chemotherapy, or primary drug resistance, or no complete hematologic remission can be achieved after 1 course of hematologic relapse chemotherapy after drug withdrawal (standard reference: NCCN,2015.2); 4. ECOG physical status rating =95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >=40%; 6. Fertile women must comply with the following requirements: Subjects must agree to use an effective contraceptive method and agree to use the same method; it is intended to continue using an effective contraceptive for at least 100 days from the date of signing of the informed consent form (ICF) to the date of receiving the infusion of this product Method; 7. The venous access required for collection can be established without contraindications to white blood cell collection; 8. Willing and able to follow the taboos and restrictions stipulated in this program.
Exclusion criteria
Exclusion criteria: 1. Patients had uncontrolled infectious diseases within 4 weeks before enrollment; 2. Hepatitis B/C virus; 3. Human immunodeficiency virus (HIV) serotype positive; 4. Had other primary tumors other than acute myeloid leukemia; 5. Suffer from serious autoimmune diseases or immunodeficiency diseases; 6. The patient is allergic and allergic to macromolecular biological drugs such as antibodies or cytokines; 7. The following cardiac conditions: New York Heart Association (NYHA) stage III or IV congestive heart failure; Into the group of former 6 or less had had a myocardial infarction or had undergone coronary artery bypass bypass (CABG) within 3 months; Ventricular arrhythmias of clinical significance, or a history of unexplained syncope, non-vasovagal or not due to dehydration; A history of severe non-ischemic cardiomyopathy; cardiac function was assessed by echocardiography or multiple circuit detection (MUGA) scan (performed within 8 weeks or less before single blood collection) can be damaged (LVEF < 45%); 8. To the detriment of the subjects acceptance or tolerance of planned treatment at the research center, understanding of any question of informed consent, or any condition that the researcher believes is not in the subjects best interests to participate in the study (for example, to impair health) , or any condition that may prevent, restrict, or obfuscate the evaluation of the provisions of the research programme; 9. Pregnant or lactating women; 10. Patients considered by the investigator to be excluded from the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index; | — |
Countries
China
Contacts
Public ContactJiang Yirong
Dongguan People's Hospital
Outcome results
None listed