Efficacy of anti-CD19 chimeric antigen receptor modified T(CAR-T) cell therapy in Chinese patients with relapsed/refractory acute lymphocytic leukemia in a multicenter trial.

Authors

null

Lei Xiao

Innovative Cellular Therapeutics Co., LTD., Shanghai, China

Lei Xiao , He Huang , Xiaojun Huang , Xiaoyan Ke , Yu Hu , Junmin Li , Qing Zhang , Yongxian Hu , Qian Jiang , Jiong Hu , Hongmei Jing , Xiaohong Zhang , Zhao Wu

Organizations

Innovative Cellular Therapeutics Co., LTD., Shanghai, China, The First Affiliated Hospital, Zhejiang University, Hangzhou, China, Peking University People's Hospital, Beijing, China, Peking University Third Hospital, Beijing, China, Union Hospital Tongji Medical College Huazhong Universtiy of Science and Technology, Wuhan, China, Ruijin Hospital, Shanghai Jiaotong University, Shanghai, China, Guangdong No.2 Provincial People's Hospital, Guangzhou, China, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China

Research Funding

Pharmaceutical/Biotech Company

Background: r/r B-ALL was reported as the most-threatening disease because of the low disease free survival even treatment with allogeneic hematopoietic stem cell transplantation. For overcoming conventional therapies limitation, autologous CD19CAR-T was performed in our clinical trials to induce remission in patients with r/r disease. 30 patients (from 7 clinical centers, in China) as volunteers with r/r B-ALL were treated by autologous CD19 CAR-T. Methods: 5 juveniles and 25 adults with r/r ALL received autologous CD19 targeted CAR-T, the doses between 1.03 × 106 CAR-T cells/kg and 10.09 × 106CAR-T cells/kg. These 30 cases(from 7 clinical centers, in China) were treated with CAR-T cells from May. 8 2015 to January. 4 2017 (Table1). Patients were monitored for a response. Highly standardized CAR T cell preparation protocol and manageable CRS in most were kept for no significant difference in 7 clinical centers. Results: After treated with CAR-T, a total of 30 cases (5 juveniles and 25 adults coming from 7 clinical centers, in China) with r/r B-ALL were all detected the CAR-T cells proliferated in the blood and bone marrow. The results showed that complete remission (CR) is 26/30(86.67% ) between day7-14 after CD19 CART cell infusion, and 25/30(83.33%) cases arrived at MRD negative. There is about 1/3 of the total cases receiving a repeat infusions following initial ones since these patients have no safety concerns. Additionaly, the severe Cytokine release syndrome (CRS) was 8/30(26.67%) of cases and 24/30(80%) of cases was seen CRS. The anti-IL6R agent tocilizumab and Methylprednisolone were effective confrontation Severe CRS. Conclusions: This is the first multicentre report to our knowledge of successful treatment of r/r ALL with anti-CD19 CAR T cells in China. Even r/r B-ALL with high-burden leukemia patients also was effective and associated with a high remission rate after infused autologous CD19 CAR-T).(NCT 02813837).

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Track

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Sub Track

Acute Leukemia

Clinical Trial Registration Number

NCT 02813837

Citation

J Clin Oncol 35, 2017 (suppl; abstr 7028)

DOI

10.1200/JCO.2017.35.15_suppl.7028

Abstract #

7028

Poster Bd #

228

Abstract Disclosures