Refractory Leukemia Clinical Trial
Official title:
Safety and Preliminary Efficacy of JK500 Cell Injection in Relapsed/Refractory Pediatric Acute Myeloid Leukemia
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | December 2025 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Institute of Hematology & Blood Diseases Hospital | Bejing Institute for Stem Cell and Regenerative Medicine, Institute for Stem cell and Regeneration, Chinese Academy of Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicity (DLT) | DLT evaluation is defined as adverse events or laboratory abnormalities that occur within 4 weeks after investigational drug administration, are unrelated to external causes such as progressive disease, concomitant disease, and concomitant medications, including hematologic and non-hematologic adverse events (grade according to NCI CTCAE 5.0). | 28 days | |
Secondary | Objective Response Rate (ORR) | ORR was defined as complete response (CR)+ incomplete bone marrow recovery (CRi) + partial response (PR). Treatment response will be assessed periodically until the end of treatment and up to 24 months after the first injection. | 24 months | |
Secondary | Minimal Residual Disease (MRD) | To observe the MRD status in bone marrow. | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05043571 -
CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia
|
Phase 1 | |
Active, not recruiting |
NCT04874480 -
Tegavivint for the Treatment of Relapsed or Refractory Leukemia
|
Phase 1 | |
Completed |
NCT04597086 -
Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients
|
N/A | |
Recruiting |
NCT05495035 -
Study for Safety and Efficacy of Olverembatinib Combined With APG-2575 in Children With Relapsed/Refractory Ph + ALL
|
Phase 1 | |
Withdrawn |
NCT05321940 -
Safety Trial of STING-dependent Activators and Stimulated Dendritic Cells for Aggressive Relapsed/Refractory Leukemias
|
Phase 1 | |
Recruiting |
NCT04722952 -
PD-1 Inhibitor Combined With Azacytidine and Homoharringtonine,Cytarabine, G-CSF for Refractory or Relapsed AML
|
Phase 3 | |
Recruiting |
NCT04684472 -
Modified CD19 CAR-T in Patients With Relapsed or Refractory CD19+ B-cell Malignancies
|
Phase 1 | |
Recruiting |
NCT04470947 -
Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies
|
||
Recruiting |
NCT04282811 -
Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy
|
||
Recruiting |
NCT05046444 -
Solving Riddles Through Sequencing
|
||
Recruiting |
NCT05576532 -
Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia
|
Phase 2 | |
Recruiting |
NCT05164042 -
Allogeneic CD19 CAR-T Cells for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
|
Phase 1/Phase 2 | |
Completed |
NCT02512926 -
Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children
|
Phase 1 | |
Recruiting |
NCT05870995 -
Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia
|
Phase 2 | |
Recruiting |
NCT03799224 -
Decitabine Plus mBU/CY Preconditioning for Relapse/Refractory Acute Leukemia
|
Phase 2/Phase 3 | |
Recruiting |
NCT06006403 -
Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
|
Phase 1/Phase 2 | |
Completed |
NCT00880269 -
Efficacy and Safety of Panobinostat (LBH5789) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
|
Phase 2 | |
Recruiting |
NCT05305859 -
Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML
|
Phase 2 |