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Adoptive Cell Therapy Against Triple-Negative Breast Cancer Using a Novel tMUC1 Antibody-Derived CAR

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[Technical Report, Annual Report]

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In the previous three reports, Tasks 1, 2, and 3 Aim 1 were completed. Most of Takes 4, 5, 6, and 7 Aim2a, 2b, 2c were accomplished. Tasks 8, 9, 10 Aim3 were started and partially finished. In brief, we successfullygenerated the 2nd generation CAR T cells, and completed cytolysis assays against TNBC cell lines in an antigen-specificmanner. Part of the in vivo experiments outlined in specific aim 2 had been completed and is published. We completedthe efficacy study of human CAR Tanti-PD1 blocking antibody treatment in the NSG mouse model of human TNBC.We successfully generated the murine CAR t cells and conducted in vitro functional assays using murine breast cancercell lines. The efficacy of murine CAR t cells in orthotopic implantation model were completed using MUC1.Tg mice andno significant tumor reduction was observed. We achieved a significant reduction for tumor growth and progression aswell as overall mouse survival in mouse CAR t cell group in spontaneous MMT tumor model, which lasted over 5months. We received five breast cancer patient PDX samples and complete their MUC1 expression profile. Weestablished the human tumor explant model with 2 PDX samples. In this cycle, we report the progress we made tocomplete the project. We successfully made the 3rd generation CAR T cells, and completed cytolysis assays againstTNBC cell lines. The rest portion of work in Task 4 and 5 are started. We completed the efficacy and toxicity evaluationof murine CAR t cells in spontaneous MMT tumor model in vivo, and its associated endpoint studies in Task 7. Wecompleted in vivo passage of 2 TNBC PDX samples and made sufficient tissue stocks for Task 10. We made sufficienthuman CAR T cells for Task 10

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[A, Approved For Public Release]