FDA Stops Ongoing Trial Exploring Novel Therapy in Pancreatic and Prostate Cancer

An ongoing phase 1/2 was put on hold by the Food and Drug Administration after the death of a patient with pancreatic cancer.

The Food and Drug Administration (FDA) placed a hold on an ongoing phase 1/2 dose-escalation study of the GoCAR-T product candidate BPX-601 for patients with previously treated metastatic pancreatic or prostate cancer, according to a press release from the product’s manufacturer, Bellicum.

The hold is meant to address a patient death that occurred in the trial, which the clinical investigator and manufacturer are stating is unrelated to BPX-601 and another agent rimiducid.

The manufacturer stated it plans to work closely with the agency to address any of its questions and fulfill the necessary requirements to resume the trial.

BPX-601 is a GoCAR-T product candidate that incorporates inducible MyD88/CD40 (iMC), which is designed to help increase the production and persistence of T cells, as well as the production of immunomodulatory cytokines that enable the CAR-T to override any mechanisms inhibiting immune response.

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