Clinical Efficacy of Humanized Anti-CD19 Chimeric Antigen Receptor T Cells in the Treatment of Acute B Lymphocytic Leukemia.
10.19746/j.cnki.issn.1009-2137.2019.05.001
- Author:
Xiao HAN
1
;
Chun-Ying YE
1
;
Chang-Xiao ZHANG
1
;
Hai CHENG
1
;
Kun-Ming QI
1
;
Wei CHEN
1
;
Jiang CAO
2
;
Kai-Lin XU
1
Author Information
1. Department of Hematology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou 221002, Jiangsu Province, China.
2. Department of Hematology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou 221002, Jiangsu Province, China,E-mail:zimu05067@163.com.
- Publication Type:Journal Article
- MeSH:
Adult;
Animals;
Child;
Humans;
Leukemia, B-Cell;
therapy;
Mice;
Receptors, Antigen, T-Cell;
Receptors, Chimeric Antigen;
T-Lymphocytes;
Treatment Outcome
- From:
Journal of Experimental Hematology
2019;27(5):1353-1359
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the safety and effectiveness of humanized CD19-targeted CAR-T cells (hCART19s) for treatment of patients with refractory/relapsed (R/R) B-ALL.
METHODS:The analyzed patients were 15 children and adults with relapsed/refractory B-ALL who not received treatment with murine CD19 CAR-T cells. The patients received a single dose (1×10/kg) of autologous hCART19 infusion after lymphodepletion chemotherapy based on cyclophosphamide and fludarabine.
RESULTS:Among the 15 patients, 13/14 (92.9%) evaluable patients achieved complete remission (CR) or CR with incomplete recovery of blood cells (CRi) on day 30 after hCART19s infusion. At day 180 after the infusion, the overall survival rate was 73.3%, and the leukemia-free survival rate was 69.2%. The cumulative incidence of relapse was 24.5% and non-relapse mortality rate was 7.7%. During treatment,12/15 patients (80%) developed cytokine release syndrome (CRS) of grade 1-2, and 3 patients (20.0%) developed CRS of grade 3-5. Only one patient (6.7%) suffered from the reversible neurotoxicity.
CONCLUSION:hCART19s can effectively treat refractory/relapsed (R/R) adult and children with B-ALL, and the incidence of treatment-related CRS and neurotoxicity is low.