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FDA Puts Clinical Holds on "Off-the-Shelf" CAR-T Trials

Jason Harris
Published: Tuesday, Sep 05, 2017

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Following the death of a 78-year-old man being treated for blastic plasmacytoid dendritic cell neoplasm (BPDCN), the FDA placed clinical holds on 2 phase I trials investigating a gene-edited allogeneic CAR T-cell (UCART) therapy known as UCART123.

. Researchers observed antitumor activity in 2 of 6 of the relapsed patients during the period of CD19-CAR-T cell persistence, whereas 2 patients who received cells while in remission remained disease-free. Of these 2 patients, 1 remained in CR for more than 8 months and the other remained in CR for 8 weeks after CAR-T infusion.
Liu, Zhong JF, Zhang X, Zhang C. Allogeneic CD19-CAR-T cell infusion after allogeneic hematopoietic stem cell transplantation in B cell malignancies. J Hematol Oncol. 2017;10(1):35. doi: 10.1186/s13045-017-0405-3.

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