The FDA has issued a clinical hold on Bellicum Pharmaceuticals for its ongoing phase 1/2 trial evaluating CAR-T therapy BPX-601 in patients who received prior treatment for metastatic pancreatic or prostate cancer, following the death of a trial participant.

The Houston, Tex., drugmaker says the death was unrelated to BPX-601 and plans to work with the FDA to resolve any lingering questions so it may resume the study.

The company also said the hold does not interfere with enrollment of an upcoming phase 1/2 trial evaluating similar CAR-T immunotherapy drug BPX-603 in breast cancer patients with solid tumors.