jCyte Initiates Patient Dosing in Phase 2 JC02-88 Trial of jCell for RP

jCyte announced that the first patients have been enrolled and treated in the JC02-88 study, a phase 2 clinical trial evaluating the safety and efficacy of jCell (famzeretcel) for the treatment of retinitis pigmentosa (RP). The study is testing a jCell dose about 50% higher than the highest dose administered in prior jCyte trials.

“The initiation of patient dosing in this trial marks an important milestone in our mission to bring a breakthrough treatment to the majority of RP patients who currently have limited treatment options,” said John Sholar, Chief Executive Officer of jCyte. “jCell has the potential to help restore vision in patients with RP, regardless of genetic subtype, and we look forward to sharing updates as the study progresses."

The phase 2 JC02-88 trial is designed to evaluate the safety, tolerability, and efficacy of a single 8.8 million cell injection of jCell in patients with RP. The study will enroll up to 60 patients aged 18–60 years across genetic subtypes of RP who meet study criteria. Participants will receive either jCell or a sham (control) treatment and will be monitored over 6 months for safety outcomes and changes in visual function.

All patients will receive treatment at the UC Irvine Gavin Herbert Eye Institute, regardless of the clinical site at which they enroll. Following the trial, a planned extension study will enable long-term monitoring of all patients and provide the opportunity for those randomized to sham control to receive jCell.

The trial is supported by the Gavin Herbert Eye Institute, the UCI GMP Facility, Lexitas, and the California Institute for Regenerative Medicine (CIRM).

For more information on the study, click here.