Safety and Preliminary Efficacy of JK500 Cell Injection in Relapsed/Refractory Pediatric Acute Myeloid Leukemia

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Aug 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JK500 cell injection for children with relapsed or refractory acute myeloid leukemia (AML), which means their leukemia did not respond to standard treatments or came back after getting better. The researchers want to see if this treatment is safe and if it might help these children. They are looking for 12 participants who are under 18 years old and have been diagnosed with AML. Specifically, children who have not achieved complete remission (CR) after two rounds of standard therapy or who have had a recurrence within six months are eligible to participate.

If your child is eligible and decides to participate, they will receive the JK500 cell injection at a single medical center. The study is currently recruiting participants, and the child's parent or guardian will need to understand the study's purpose and give consent before joining. It’s important to note that some children may not qualify due to specific health issues or recent medical treatments. The goal of this trial is to gather important information that could help improve future treatments for children facing this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≤18, male or female;
• • 2. Patients diagnosed as acute myeloid leukemia (AML) according to the revised World Health Organization (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 the subject as the subject, and sign the informed consent.
• 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:
• • 1. Serum creatinine \>2× upper limit of normal reference value;
• • 2. Serum total bilirubin \> 2× upper limit of normal reference value;
• • 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2× 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.