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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
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• Age ≤18, male or female;

• Patients diagnosed as acute myeloid leukemia (AML) according to the revised World Health Organization (WHO) criteria in 2016;

• Patients who failed to achieve CR after two standard-dose induction therapy or had recurrence within six months after CR;

• 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.

Locations
Other Locations
China
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
Min Ruan, MD
ruanmin@ihcams.ac.cn
+8613602177144
Time Frame
Start Date: 2022-09-14
Estimated Completion Date: 2025-12
Participants
Target number of participants: 12
Treatments
Experimental: JK500 cell injection
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.
Related Therapeutic Areas
Acute Myeloid Leukemia (AML)
Childhood Acute Myeloid Leukemia
Leukemia
Sponsors
Collaborators: Bejing Institute for Stem Cell and Regenerative Medicine, Institute for Stem cell and Regeneration, Chinese Academy of Sciences
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov

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