Ziopharm gets hit with a clinical hold as FDA red lights human study using their fast-built CAR-T
One of Ziopharm’s $ZIO heavily touted, fast-built CAR-Ts isn’t ready for a human trial just yet.
The biotech reports that the FDA has dropped a clinical hold on their Phase I study of a CAR-T that can be built in 2 days to express CD-19, IL-15 and a safety switch for CD-19/positive leukemias and lymphomas. But regulators want to know more about the chemistry and manufacturing, according to the company, so they put on a hold that may delay the start of the study.
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