A Phase 1 interventional study of Chimeric antigen receptor T cells and peptide specific dendritic cell in Leukemia, Acute Lymphocytic (ALL), Leukemia, Acute Myelogenous (AML) and Myelodysplastic Syndromes, sponsored by Zhujiang Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Zhujiang Hospital · Phase 1, Interventional, and Treatment
The main purpose of this study is to verify the safety and potential effectiveness of CART cells combined with peptide specific dendritic cell in relapsed/refractory leukemia.
A prospective study to evaluate the safety and efficacy of Chimeric antigen receptor T cells combined with Eps8 or WT1(Wilms tumor 1) peptide specific dendritic cell for patients with relapsed/refractory leukemia. There are options for CAR-targets: CD19, CD20, CD22 and CD10 for acute lymphoblastic leukemia; CD33, CD38 CD56, CD117, CD123, CD34 and Muc1 for acute myeloid leukemia and Myelodysplastic Syndrome. Progression free survival, overall Survival, overall response rate, and duration of response were monitored.
Relapsed/Refractory leukemia patients:
Exclusion Criteria:
CAR-T cells combined with Eps8 peptide specific dendritic cell,or CAR-T cells combined with WT1 peptide specific dendritic cell
Biological: Chimeric antigen receptor T cells · Biological: peptide specific dendritic cell
After pretreatment, chimeric antigen receptor T cells will be transfused.
Biological: Chimeric antigen receptor T cells
After pretreatment, chimeric antigen receptor T cells will be transfused.
Also known as: CAR-T
After transfusion of chimeric antigen receptor T cells, Eps8 or WT1 peptide specific dendritic cell were intradermal injected.
Also known as: WT1 peptide specific dendritic cell, Eps8 peptide specific dendritic cell
Occurrence of study related adverse events, according to NCI CTCAE Version 4.0
Incidence and severity of cytokine release syndrome(CRS): The systemic inflammatory response in patients with significantly increased IL-6 and other cytokines during the observation period is defined as CRS, which is divided into 1-5 grades, 1-2 Grade is mild, grade 3-5 is severe
Time frame: up to 12 months
Progression free survival time
Time from random to the first occurrence of disease progression.
Time frame: 2 years
Overall survival time
Time from randomization to death due to any cause
Time frame: 2 years
Overall response rate
The proportion of the total number of patients with complete remission and partial remission (CR+PR) after treatment in the total number of evaluable cases
Time frame: 2 years
Duration of response
During the observation period, the time between complete remission of bone marrow (the ratio of bone marrow blast cells is less than 5%) to the recurrence of bone marrow (the ratio of bone marrow blast cells is greater than 5%) is the continuous remission time.
Time frame: 2 years
Plan to share: No
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Zhujiang Hospital