Online Program

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Tuesday, September 24
Tue, Sep 24, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

WITHDRAWN: TL12: Statistics Considerations in CAR-T and Cell Therapy Dose-Finding Studies (300814)

*Xiaoling Wu,  

Keywords: dose finding Bayesian CAR-T

With the development of tumor immunotherapy, the therapeutic potential of cellular immunotherapy in malignant tumors has received more and more attention. Among them, chimeric antigen receptor T lymphocytes (CAR-T) show attractive therapeutic prospects in the treatment of lymphoid hematopoietic malignancies such as B lymphocytic leukemia, B cell lymphoma and multiple myeloma. CAR-T cell therapy is a cutting-edge product. However, it is not yet clear the dose finding approach developed for existed cancer target are suitable for CAR-T or other cell therapies. I will first go over the existed approaches such as 3+3, BLRM, BOIN and other Bayesian adaptive designs. And the challenges of finding MTD of CAR-T therapy. Challenges include precise and replicable manufacture of CAR-T positive cells, incorporating cellular kinetics and other biomarkers, and whether to utilize efficacy information for various tumor malignancy. The discussion will be interactive and inclusive. I will invite statistician from regulatory agency, industry and academic to share their insights. At the end of the round table discussion, participants should have a better understanding of the dose finding strategy applied to CAR-T cell therapy and the treatment itself.