The U.S. Food and Drug Administration (FDA) have approved a new Investigational New Drug (IND) application for a novel cell therapy called CLBR001+SWI0I9 leading to an imminent Phase I clinical trial of a new CAR-T technology centering on “switchable” cells that can eliminate life-threatening side-effects that materially impede this powerful class of therapy. The technology has been developed by an elite California research institution.
Sponsored by an interesting partnership bringing together a California research organization associated with Scripps Research called Calibr and multinational biopharma company AbbVie the duo came together in 2018 to develop the drug, affording the Illinois-based company exclusive access to the technology for up to four years the two reported in a press release.
TrialSite News offers a brief breakdown of this situation.
What is the New CAR-T based therapy being tested for?
The sponsors seek to test the therapy on certain blood cancers such as relapsed/refractory B-cell malignancies such as non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.
Is CLBR001+SWI0I9 Made from a Patient’s own T-cells?
Yes, just like other CAR-T therapi...
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