Pharma Focus Asia

Cellenkos Receives Approval to Proceed with CK0803 Neurotrophic T Regulatory Cell Therapy for Second Cohort in ALS Trial

Tuesday, February 20, 2024

Cellenkos® has shared positive safety findings regarding its innovative CK0803 neurotrophic T regulatory (Treg) cell therapy, designed for Amyotrophic Lateral Sclerosis (ALS) treatment. Approval to treat the second patient group in the trial ( NCT05695521) was granted following a safety data review by the Data Safety Monitoring Board (DSMB).

Tara Sadeghi, Cellenkos' Chief Operating Officer, expressed enthusiasm, stating, "The DSMB's recommendation marks a significant step toward bringing this potentially disease-altering therapy to ALS patients, moving us closer to our goal of curing ALS."

CK0803, developed using Cellenkos' proprietary CRANE® technology, is a neurotrophic, allogeneic, umbilical cord blood-derived Treg cell therapy targeting inflamed microglia. Completion of dosing for cohort 1 allows for continued enrollment in the Phase 1 Safety Run-in Study, followed by a Phase 1b Randomized, Double-Blind, Placebo-Controlled Trial of CK0803 in ALS patients. The treatment regimen consists of four weekly infusions followed by five monthly infusions.

The Regulatory T Cells for Amyotrophic Lateral Sclerosis (REGALS) study, conducted across multiple centers including Columbia University, New York; Michael E. DeBakey VA Medical Center, Houston; and Baylor College of Medicine, Houston, aims to establish the safety and tolerability of multiple doses of CK0803 in ALS patients. Additionally, the study will provide preliminary efficacy data using endpoints such as the combined assessment of function and survival (CAFS) and longitudinal measurement of neurofilament light chain levels in serum and cerebrospinal fluid (CSF).

Amyotrophic Lateral Sclerosis (ALS) is a group of rare neurological diseases characterized by the degeneration of nerve cells responsible for voluntary muscle movement. Currently, there is no cure for ALS, and available treatments only offer limited relief from symptoms.

CK0803, a novel allogeneic cell therapy product, utilizes T regulatory cells with a high expression of CD11a to engage with inflamed microglia via the CXCR3/CXCL10 axis. Manufactured from clinical-grade umbilical cord blood units using Cellenkos' proprietary CRANE® process, CK0803 does not require HLA or ABO matching to the recipient. Its cryopreserved form allows for easy storage and infusion in outpatient settings, making it an ideal therapy for ALS patients.



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