JK500 cell injection for children with relapsed or refractory acute myeloid leukemia
Safety and Preliminary Efficacy of JK500 Cell Injection in Relapsed/Refractory Pediatric Acute Myeloid Leukemia
This study is testing a new cell injection treatment for children with relapsed or hard-to-treat acute myeloid leukemia to see if it is safe and helps them feel better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05519384 on ClinicalTrials.gov |
What this trial studies
This clinical trial is an exploratory study focusing on the safety and preliminary efficacy of JK500 cell injection in treating children with relapsed or refractory acute myeloid leukemia (AML). It involves a single-center, single-arm approach where 12 pediatric patients will receive JK500 cell injections, which are derived from regenerative natural killer (NK) cells from human embryonic stem cells. The study aims to evaluate both the safety of the infusion and the initial effectiveness of this treatment method. Additionally, patients will also receive cyclophosphamide and fludarabine as part of their treatment regimen.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 18 or younger who have been diagnosed with relapsed or refractory acute myeloid leukemia.
Not a fit: Patients with acute promyelocytic leukemia, chronic myelocytic leukemia, or those with active viral infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children with difficult-to-treat forms of acute myeloid leukemia.
How similar studies have performed: While this approach is novel, similar studies involving regenerative cell therapies have shown promise in other hematological conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin, Tianjin
- Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Xiaofan Zhu — Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
- Study coordinator: Min Ruan, MD
- Email: ruanmin@ihcams.ac.cn
- Phone: +8613602177144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.