Acute myeloid leukemia
Conditions
Interventions
Single arm:intravenous infusion of CAR T cells
Sponsors
Xuzhou Medical College affiliated hospital
Eligibility
Sex/Gender
All
Age
2 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities; 2. At the age of 2-70 years old; 3. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML); 4. The patient has recovered from the toxicity of previous treatment; 5. ECOG score = 60 mL/min; Hemoglobin >= 60g/L ; Indoor oxygen saturation >= 92%; LVEF>= 45%; 7. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test; 8. From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception
Exclusion criteria
Exclusion criteria: 1. Diagnosis of acute promyelocytic leukemia; 2. History or presence of a CNS disorder; 3. HBsAg is positive; HCV HIV or Syphilis antibody are positive, CMV DNA in peripheral blood is more than>= 500 copies/mL; 4. History of severe hypersensitivity reaction; 5. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment; 6. History of organ transplant surgery; 7. Required systemic application of immunosuppressive or other drugs; 8. Auto-SCT within the 3 months before enrollment; 9. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)); 10. Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TL); 11. Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management; 12. Live vaccine received within the <= 4 weeks before enrollment; 13. Persons with serious mental illness; 14. History of major surgical operations four weeks before enrollment; 15. History of alcoholism or substance abuse; 16. Was identified by the investigators as unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index;Pharmacokinetic (PK) and pharmacodynamic (PD) evaluation;Efficacy evaluation index; | — |
Countries
China
Contacts
Public ContactZhenyu Li
Outcome results
None listed