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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
After pretreatment, chimeric antigen receptor T cells will be transfused.
After transfusion of chimeric antigen receptor T cells, Eps8 or WT1 peptide specific dendritic cell were intradermal injected.
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGOccurrence 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
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