Day 1 :
Innovative Cellular Therapeutics, China
Keynote: Potent anti-leukemia activities of chimeric antigen receptor modified T (CAR-T) cell therapy in Chinese patients with relapsed/refractory hematological malignances
Time : 13:35-14:20
Background: Patients with relapsed/refractory hematological malignances, including acute lymphocytic leukemia as well as lymphoma, have a poor prognosis. Chimeric antigen receptor modified T cells against CD19 have displayed anti-malignance activities. Autologous CD19CAR-T performed in our clinical trials induced remission in patients with r/r hematological malignances. 41 subjects (from 10 clinical centers, in China) with r/r B-ALL and two subjects with non-Hodgkin's Lymphoma (NHL) were treated by autologous CD19 murine CAR-T cells (NCT 02813837). Another two subjects with r/r B-ALL were treated by autologous CD19 humanized CAR-T cells.
Methods: 41 subjects with r/r B-ALL and two subjects with r/r NHL were treated with murine CAR-T cells from May 8, 2015 to January 30, 2017, while three subjects with r/r B-ALL were treated with humanized CAR-T cells from December 16, 2016 to December 27, 2016. Both the murine and humanized CAR-T cells were infused with dose range between 0.45 × 106 CAR-T cells/kg and 10.51 × 106 CAR-T cells/kg. All subjects were monitored closely during the trial. Both murine and humanized CAR-T cells were prepared according to in-house built robust protocol to ensure quality.
Results: Following treatment with CD19 murine/humanized CAR-T cells, the proliferation of CAR-T cells were detected with both qPCR and flow cytometry techniques in blood and bone marrow samples in all clinical subjects. 34/41(82.93%) subjects with B-ALL achieved complete remission (CR) between 7 to 14 days after murine CD19 CART cell infusion, and 33/41(80.49%) subjects arrived at MRD negative. Additionally, Severe Cytokine Release Syndrome (CRS) was observed in 12 subjects (29.3%) and another 21 subjects have shown low-grade CRS symptoms (51.2%). Severe CRS subjects were adequately managed by anti-IL6R Tocilizumab and corticosteroid anti-inflammatory drugs. Two subjects with NHL achieved CR after CD19 murine CAR-T cells infused and neither of them suffered from irreversible neurotoxicity. Both two subjects with B-ALL treated with humanized CAR-T cells achieved CR as well as MRD negative.
Conclusions: This is the first multicentre report to our knowledge of successful treatment of r/r B-ALL with CD19 CAR T cells in China. Even r/r B-ALL with high-burden leukaemia patients also was effective and associated with a high remission rate after autologous CD19 CAR-T infusion (NCT 02813837). In addition, though the follow-up is short, CD19 murine CAR-T cells showed potent efficacy in subjects with NHL, meanwhile subjects with r/r B-ALL might benefit from CD19 humanized CAR-T cells therapy.
Lei Xiao is the Chairman and CSO of Innovative Cellular Therapeutics Co., Ltd. His research interests include chimeric antigen receptor T cells therapy, iPS cell technology & human embryonic stem cells and Gene therapy. During October 2005 - September 2010 he worked as Principal Investigator in Shanghai Institute of Biochemistry and Cell Biology. During January 2007 - September 2010, he was the Director of Cell Bank/Stem Cell Bank of Chinese Academy of Sciences, Shanghai Institute for Biological Sciences. He was a Professor at Zhejiang University from 2010 to 2015. From August 2009 to present, he is a Chief Science Officer at the Innovative Cellular Therapeutics Co., Ltd., which was formerly Shanghai SiDanSai Biotechnology Co, Ltd.
Umm Al Qura University, Saudi Arabia
Keynote: Soluble carcinoembryonic antigen cell adhesion molecule 1,6 and 8 in acute myeloid leukemia: their relation to survival and prognosis
Time : 09:30-10:15
Amal zaghloul has completed her medical doctorate in clinical pathology with specialty in hematology at the age of 34 years from faculty of medicine Ain shams University Cairo Egypt. She is a professor of clinical pathology (hematology) at faculty of medicine Umm Alqura University (Saudi Arabia) and at faculty of medicine Ain Shams university (Cairo Egypt). She has participated in both theoretical and practical teaching of Hematology. Also, supervising research works of under and postgraduate students. She has experience in the flow cytometry, immunohistochemistry and ELISA . She has published more than 25 papers in reputed journals