Precision BioSciences reports patient death in PBCAR0191 Phase 1/2a trial

Precision BioSciences, which earlier announced "positive" interim clinical results from its Phase 1/2a study of PBCAR0191, the company's off-the-shelf allogeneic CAR T cell therapy investigational candidate targeting CD19, also announced that in this dose escalation and dose expansion study, PBCAR0191 had "an acceptable safety profile" with no cases of GvHD, no cases of Grade greater than or equal to 3 CRS, and no cases of Grade greater than or equal to 3 ICANS. In the press release, the company noted: "One NHL patient who was treated with PBCAR0191 and eLD had previously received nine prior lines of therapy before entering the trial. The patient presented with persistent cytopenias at baseline and a history of infections, including bacterial sepsis. The patient had an episode of sepsis at day 27 which appeared to have resolved at day 33, following which a partial response was achieved at day 34. Unfortunately, the patient died at day 42 with grade 5 sepsis." Chris Heery, Chief Medical Officer at Precision BioSciences, added: "We are rapidly leveraging learnings from this study and enrolling more patients into our enhance lymphodepletion regimen. In parallel, we continue to evaluate higher cell doses, repeat dosing and other novel methods to further optimize our dosing strategy. We also plan to pursue clinical development of PBCAR19B, our CD19 Stealth Cell candidate, which has shown to delay both T cell and natural killer cell mediated allogeneic rejection in vitro. We believe this is likely to result in improved persistence of allogeneic CAR T cells. We expect to move PBCAR19B into the clinic in 2021."