relapsed/refractory pediatric acute myeloid leukemia
Conditions
Interventions
The treatment group:JK500 cell injection
Sponsors
Institute of Hematology, Blood Disease Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age <= 18, male or female; 2. Patients diagnosed with acute myeloid leukemia according to the revised WHO criteria in 2016; 3. Patients who failed to achieve CR after two standard-dose induction therapy or had recurrence within six months after CR; 4. The subject or the guardian of the subject must fully understand the purpose, nature, method, and possible adverse reactions of the test, agree on the subject as the subject, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia, chronic myelocytic leukemia, acute mixed-cell leukemia or known central nervous system leukemia; 2. AML associated with congenital syndromes such as Down syndrome, Fanconi's anemia, Bloom's syndrome, Koch's syndrome, or congenital aplastic anemia; 3. The subjects have active virus infection, and during the screening period, the serum virology test is performed, and the human immunodeficiency virus (HIV) antibody is positive, hepatitis B surface antigen or E antigen is positive, hepatitis C antibody is positive, or treponema pallidum antibody is positive; 4. Presence of active systemic infection; Participated in a drug trial within the past 4 weeks; 5. Patients who suffered from a clinically significant disease within 28 days before receiving the study product or underwent a major surgical operation within 28 days before receiving the study product, or are expected to need major surgery during the trial; 6. children with liver and kidney dysfunction, including: Serum creatinine > 2 x upper limit of normal reference value; Serum total bilirubin > 2 x upper limit of normal reference value; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x upper limit of normal reference values 7. Children who have used live attenuated vaccine 4 weeks before administration or plan to use live attenuated vaccine within 6 months after administration; 8. Have any other conditions that may cause the subject to be unable to complete the study or present a significant risk to the subject in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of infusion;Post infusion safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone marrow morphology;Minimal residual disease; | — |
Countries
China
Contacts
Public ContactZhu Xiaofan
Outcome results
None listed