Poseida suspends CAR T therapy trial in prostate cancer due to patient death

pharmafile | August 18, 2020 | News story | Manufacturing and Production, Research and Development CAR T, CAR-T, Poseida, patient death, pharma 

Poseida’s Phase 1 trial that used an investigational CAR T therapy for treating prostate cancer has been suspended due to a patient death.

The trial, called P-PSMA-101, has been put on hold by the FDA with the company’s share prices plunging as much as 38% on Monday. The patient who died had previously undergone a failed treatment with multiple anti-cancer agents. They died of hepatic failure 19 days after being treated on the trial where they had developed symptoms consistent with macrophage activation syndrome (MAS). 

The company said that MAS can be caused by CAR T therapies making the immune system overreact, but it can also be caused by infection or autoimmune disease. 

Prior to their death, the patient had registered normal results and showed no symptoms that indicated an adverse reaction to the treatment. The patient then went on to miss their 10-day and 14-day follow up visits due to developing symptoms that led to their hospitalisation. 

Poseida is now waiting for a formal response from the FDA and is assessing the circumstances around the death while analysing possible protocol changes. 

In a statement, the company said: “To date, there have been no other serious adverse events of decreased vision, uveitis, MAS, or hepatic failure reported in study P-PSMA-101-001. There has also been no cytokine release syndrome or neurotoxicity reported.”

Conor Kavanagh

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