Cellenkos has dosed the first patient in a Phase I/Ib trial assessing its cell therapy CK0803 to treat amyotrophic lateral sclerosis (ALS).

CK0803 is a neurotrophic, allogeneic, umbilical cord blood-derived T regulatory cell therapy that specially targets central nervous system.

It has been developed by using Cellenkos’ proprietary CRANE technology.

The dosing represents the commencement of the trial’s Phase I safety run-in portion that includes six patients.

This portion will be followed by a Phase Ib randomised, double blind, placebo control trial of the cell therapy in further 60 ALS patients.

During the regulatory T cells for amyotrophic lateral sclerosis (REGALS) trial, patients will receive four weekly infusions followed by five infusions per month.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

Learn more about Strategic Intelligence

The multicentre study is led by Columbia University Eleanor and Lou Gehrig ALS Center director and Neurology associate professor as well as principal investigator Neil Shneider.

Columbia University is the key site of the trial.

The Phase I trial’s primary objective is to establish the safety and tolerability of various CK0803 doses in the enrolled patients.

The Phase Ib trial will offer preliminary efficacy findings employing the primary endpoint of combined assessment of function and survival (CAFS) that ranks clinical results of patients on the basis of survival time and change in the ALS Functional Rating Scale-Revised score.

Its secondary endpoint is longitudinal measurement of neurofilament light chain levels in serum and cerebrospinal fluid.

Cellenkos chief operating officer Tara Sadeghi said: “The initiation of this study of CK0803 is an important achievement that brings us closer to delivering a potential new treatment which may have a life-changing impact for ALS.

“ALS is a devastating disease with no cure, and we believe that CK0803 has the potential to provide a much-needed treatment option for patients.”

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

Free Whitepaper

Optimise your cell therapy process: a guide to cell thawing

Typically carried out at the point of care, errors in cell therapy thawing could compromise treatment efficacy, leading to significant patient impact as well as high costs and a compromised reputation for the product’s developer. This guide addresses how cell thawing has historically developed into the new techniques used today, along with the physical and biological implications of key metrics and components such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies.

Thank you.

You will receive an email shortly. Please check your inbox to download the Whitepaper.

By Cytiva Thematic

You have a right to withdraw your consent at any time, by clicking here. We may still continue to send you service-related and other non-promotional communications. For more information relating to our privacy practices, we invite you to review our privacy policy.