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.
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.”
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