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Trial Title:
Safety and Preliminary Efficacy of JK500 Cell Injection in Relapsed/Refractory Pediatric Acute Myeloid Leukemia
NCT ID:
NCT05519384
Condition:
Acute Myeloid Leukemia, Childhood
Relapsed Leukemia
Refractory Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cyclophosphamide
Fludarabine
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
They were divided into three dose groups: 10^6, 5x10^6 and 3x10^7 JK500 cells injection
/kg/ time, three times a week, a total of 6 times.
According to the principle of dose escalation, 3 patients were assigned to each dose
group. After completing the treatment of 3 patients in each dose group, the Safety Review
Committee (SRC) discussed whether to enter the next dose group.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JK500 cell injection，cyclophosphamide，Fludarabine
Description:
After enrollment, patients received JK500 cell injection infusion after reinduction
therapy. Pretreatment regimen before cell infusion: intravenous infusion of
cyclophosphamide 60mg/kg day -7, intravenous infusion of fludarabine 25mg/㎡/day day -6 to
-2 days. In order to activate and expand circulating NK cells, on the day of each
infusion of JK500 cells, the patients were first subcutaneously injected with 100WU/ m2
of interleukin (IL)-2 0.5h-1h in advance, for a total of 6 doses.
Arm group label:
JK500 cell injection
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.
Detailed description:
The Main components of JK500 cell injection are regenerative natural killer (NK) cells
derived from human embryonic stem cells and 0.9% sodium chloride solution.
Criteria for 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.
Gender:
All
Minimum age:
N/A
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaofan Zhu, MD
Phone:
86-21-23909001
Email:
xfzhu@ihcams.ac.cn
Investigator:
Last name:
Min Ruan, MD
Email:
Sub-Investigator
Start date:
September 14, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Collaborator:
Agency:
Bejing Institute for Stem Cell and Regenerative Medicine
Agency class:
Other
Collaborator:
Agency:
Institute for Stem cell and Regeneration, Chinese Academy of Sciences
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519384
