piggyBac 转座子介导的 CAR-T 细胞疗法临床实施的挑战.pdf

1、Challenges in the Clinical Implementation of piggyBac Transposon mediated CAR-T cell TherapyShigeki Yagyu A-SEEDS Co.,Ltd.Shinshu University Innovative Research&Liaison OrganizationCMC Strategy Forum Japan 2024“Key Strategies and Harmonization Efforts on Raw Material Managements of Cell Therapies Wh

2、at for CAR-T”a-seeds.co.jp|A-SEEDS Co.,Ltd.Todays topic1.T cell composition in the starting materials-The composition of T cells in the starting materials is critical for determining the manufacturing efficiency and quality of piggyBac transposon CAR-T cell products.-Key Question 1:What strategies c

3、an be employed to optimize T cell composition in patient-derived samples,ensuring manufacturing success and the high quality of final CAR-T cell products?2.CAR-T cell driven second malignancies-Multiple factors,including vector insertion and pre-existing malignant clones,may be associated with CAR-T

4、 driven second malignancies.-Key Question 2:What are the key considerations for establishing robust vector copy number(VCN)criteria for piggyBac transposons to ensure long-term safety?a-seeds.co.jp|A-SEEDS Co.,Ltd.Todays topic1.T cell composition in the starting materials-The composition of T cells

5、in the starting materials is critical for determining the manufacturing efficiency and quality of piggyBac transposon CAR-T cell products.-Key Question 1:What strategies can be employed to optimize T cell composition in patient-derived samples,ensuring manufacturing success and the high quality of f

6、inal CAR-T cell products?2.CAR-T cell driven second malignancies-Multiple factors,including vector insertion and pre-existing malignant clones,may be associated with CAR-T driven second malignancies.-Key Question 2:What are the key considerations for establishing robust vector copy number(VCN)criter