Cellenkos, a United States-based clinical-stage biotechnology company, announced on Monday that it has received approval to commence a trial (clinicaltrials.gov: NCT05695521) with second group of patients for its innovative CK0803 neurotrophic T regulatory (Treg) cell therapy intended for the treatment of individuals with Amyotrophic Lateral Sclerosis (ALS).

The company has received approval after a review of safety data by the Data Safety Monitoring Board (DSMB) Of the US National Institutes of Health (NIH). The DSMB found none of the participants experienced any serious adverse events or dangerous side effects from the therapy.

CK0803 is a neurotrophic, allogeneic, umbilical cord blood-derived T regulatory (Treg) cell therapy that preferentially homes towards inflamed microglia, developed by using Cellenkos' proprietary CRANE technology, to generate disease-specific products.

The completion of cohort 1 dosing allows for the continued enrolment on the Phase 1 Safety Run-in Study, to be followed by a Phase 1b Randomised, Double Blind, Placebo Control Trial of CK0803 in patients with ALS. The treatment will include four weekly infusions followed by five monthly infusions.

Regulatory T Cells for Amyotrophic Lateral Sclerosis (REGALS) is a multicenter study including Columbia University, New York; Michael E DeBakey VA Medical Center, Houston and Baylor College of Medicine, Houston. The primary objective of this study is to establish safety and tolerability of multiple doses of CK0803 in ALS patients.