09:02 AM EDT, 09/30/2024 (MT Newswires) -- Calidi Biotherapeutics ( CLDI/WS ) said Monday that the US Food and Drug Administration has cleared Northwestern University's investigational new drug application for the company's CLD-101 therapy, which uses stem cells to deliver engineered oncolytic adenoviruses.

A phase 1b/2 trial of the investigational treatment is expected to begin late this year at the Northwestern University, Calidi said.

The study will evaluate the safety of giving multiple doses of CLD-101 to patients with newly diagnosed high-grade glioma, according to the company.

Shares of Calidi were down 4% in recent Monday premarket activity.

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