Overview

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

Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study is a prospective, single-center, single-arm exploratory clinical study, aiming to complete the preliminary clinical observation of 12 children with relapsed/refractory acute myeloid leukemia treated with JK500 cell injection to evaluate the safety of clinical infusion and the initial efficacy of JK500 cell injection in the treatment of children with relapsed/refractory acute myeloid leukemia.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital
Collaborators:
Bejing Institute for Stem Cell and Regenerative Medicine
Institute for Stem cell and Regeneration, Chinese Academy of Sciences
Treatments:
Cyclophosphamide
Fludarabine
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: Serum creatinine >2× upper limit of normal reference value; Serum
total bilirubin > 2× upper limit of normal reference value; 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.