Cell-ebrating the dosing of patients with jCell in a phase 2 clinical trial for RP

RP is one of the most common types of inherited retinal disease (IRD), associated with faults in over 100 genes, affecting around 25,000 people in the UK. RP causes progressive vision loss, starting peripherally, due to the loss of light-sensing rod and cone photoreceptors in the retina. To learn more about RP, please visit Retinitis pigmentosa – Retina UK.

“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. 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.” (John Sholar, Chief Executive Officer of jCyte)

jCell – What is it?

jCell, developed by jCyte, is a cell therapy that aims to preserve vision in those with RP by protecting and potentially reactivating photoreceptor cells. The treatment is delivered via an intravitreal injection with a topical anaesthetic (an injection into the jelly-like substance of the eye). This is a less invasive method of delivery compared to sub-retinal injections, used to deliver treatments such as Luxturna.

Due to its mechanism, jCell is a gene-agnostic treatment, meaning that it could potentially work for patients with any genetic form of RP. This marks a significant milestone in non-gene specific treatment development!

How does it work?

A dose of jCell results in the sustained release of neurotrophic factors, that might reduce photoreceptor death. Neurotrophic factors are essential ‘growth signals’ that bind to signals on or near photoreceptor cells. This then triggers key pathways that promote gene activity that helps to keep these cells healthy.

JC02-88 Trial – What does it involve?

JC02-88 is a phase 2 clinical trial of famzeretcel, more commonly known as jCell. It involves testing the efficacy, tolerability and safety of jCell further in a larger group of patients than in phase 1. The dosage in this trial has also been increased to 8.8 million cells in a single injection, an increase of approximately 50% in comparison to the highest dose administered in previous trials by jCyte.

JC02-88 will enrol up to 60 participants, varying in age from 18-60 years old, with any genetic form of RP that meet certain requirements. You can find out more about the participation criteria here: JC02-88 Study Patients

Patients will receive either one dose of jCell or a sham treatment as part of a control group. All patients will be treated at the UC Irvine Gavin Herbert Eye Institute (California) and will be assessed over a 6-month period to monitor safety and any changes in vision.

jCyte have also announced plans for an extension study following JC02-88, to allow for longer term monitoring of all patients and to allow patients randomized to the sham control group to be treated with jCell.

“This marks another critical milestone in our journey to develop a treatment for RP. Our team’s dedication and perseverance have brought us to this point, and we remain committed to delivering a therapy that can make a meaningful difference in patients’ lives.” (Henry Klassen, MD, PhD, Co-Founder and President of jCyte)

Although this trial will take place in the US, we look forward to hearing the results expected in 2027! For more information, please visit Retinitis Pigmentosa | Degenerative Retinal Disorders | jCyte Inc.