jCyte Launches New Phase 2 Clinical Trial for its Cell-Based RP Therapy

jCyte has begun dosing patients in JC2-088, a Phase 2, sham-controlled, clinical trial for jCells (famzeretcel), an emerging, gene-agnostic cell therapy designed to improve vision in patients with retinitis pigmentosa (RP). All trial participants will be dosed at the UC Irvine Gavin Herbert Eye Institute.

The six-month trial is enrolling up to 60 patients, 18 – 60 years of age, regardless of the mutated gene causing their RP. The 8.8 million cell dose for the trial is about 50 percent higher than the highest dose administered in previous jCell trials. Participants receiving the sham may later receive the treatment in an extension study. Trial participants must have best-corrected visual acuity between 20/800 and 20/80 and a visual field diameter of at least eight degrees in the study eye.

jCells are similar to stem cells that haven't yet fully developed into mature photoreceptors and designed to release proteins known as neurotrophic factors to preserve photoreceptors regardless of the mutated gene causing vision loss. The cells are injected into the vitreous, the soft, gel-like substance in the middle of the eye. Intravitreal injections have a good record of safety and are commonly administered for other conditions in a doctor's office.

Previously, the company reported on 76 patients in a Phase 2b trial for jCells. In the Phase 2b trial, 39 percent of patients receiving 6 million cells, the high dose of the treatment, had improvement at 12 months post-treatment in BCVA of 10 letters (two lines on an eye chart) or more, with 26 percent improving by at least 15 letters. In the sham group, 19 percent and 8 percent had BCVA improvement of 10 or more and 15 or more letters, respectively. Substantial improvements for eyes treated with 6 million jCells as compared to sham were also seen in contrast sensitivity, kinetic visual fields, and mobility-related visual function (as captured by the VFQ-48 questionnaire). The 3 million cell dose, the lower dose of treatment included in the study, was shown to be inferior to the 6 million cell dose.

jCyte had announced plans to launch a Phase 3 clinical trial for jCells in 2024, but the trial was not launched.