The FDA halted San Diego-based drugmaker Poseida Therapeutics’ clinical trial of a CAR-T therapy after a patient died, according to an Aug. 17 Securities and Exchange Commission filing.
The phase 1 trial was investigating a CAR-T gene therapy called P-PSMA-101, designed to treat prostate cancer.
The patient had metastatic castrate-resistant prostate cancer and died of liver failure 19 days after receiving the CAR-T treatment. He had missed two follow-up visits and developed symptoms that led to him being hospitalized, according to the SEC filing.
Poseida is waiting on a formal response from the FDA and preparing recommendations to allow the trial to resume, the drugmaker said.
The drugmaker’s shares fell 35 percent after the announcement.
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