Safety and persistence of genetically modified T-cells in patients with non-Hodgkin lymphoma

2017 Fiscal Year Final Research Report

• Project/Area Number: 26430168
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Tumor therapeutics
• Research Institution: Jichi Medical University
• Principal Investigator: OHMINE KEN 自治医科大学, 医学部, 准教授 (90316521)
• Co-Investigator(Kenkyū-buntansha): 塚原 智典 自治医科大学, 医学部, 講師 (10362120)
• Project Period (FY): 2014-04-01 – 2018-03-31
• Keywords: 遺伝子改変T細胞療法 / CD19抗原 / 非ホジキンリンパ腫 / 細胞疲弊化

Outline of Final Research Achievements

We are conducting a clinical trial to evaluate the safety and efficacy of administering CD19 specific CAR-Ts manufactured from a patient’s autologous T-cells to combat relapsed or refractory B-cell non-Hodgkin lymphomas. We established a protocol to manufacture a sufficient number of CAR-Ts stimulated by OKT3 onto Retronectin-coated substratum. We demonstrated small scale test using patient’s blood. The patients’ T-cells showed much lower fold expansion compared to healthy donors’. The gene transfer efficiency of patient’s T-cells was equivalent to that of healthy donors. Enrollment started in December 2014. All of seven patients had successful CAR-T production, and three patients safely received an infusion. Although clinically relevant responses seen, PCR analyses failed to show the presence of CAR-Ts in one patient. There remains a need for new therapeutic modalities. These early experiences demonstrate the feasibility and significant clinical impact of CAR-T therapy.

Free Research Field

臨床腫瘍学