CK0803 / Cellenkos - LARVOL DELTA

REGALS: Regulatory T Cells for Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1 | N=66 | Active, not recruiting | Sponsor: Cellenkos, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Amyotrophic Lateral Sclerosis • CNS Disorders • CSF NfL

Cellenkos Approved to Proceed with CK0803 Neurotrophic T regulatory Cell therapy to Treat Second Cohort in ALS Trial (PRNewswire) - "Cellenkos today announced encouraging safety data from its innovative CK0803 neurotrophic T regulatory (Treg) cell therapy, being developed to help treat individuals with Amyotrophic Lateral Sclerosis (ALS). The company can now begin treating the second group of patients in the trial....The company was given the green light to move ahead following a review of safety data by the Data Safety Monitoring Board (DSMB). The DSMB found none of the participants experienced any serious adverse events or dangerous side effects from the therapy."

DSMB • Trial status • Amyotrophic Lateral Sclerosis • CNS Disorders

REGALS: Regulatory T Cells for Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: Cellenkos, Inc. | Phase classification: P1b ➔ P1

Phase classification • Amyotrophic Lateral Sclerosis • CNS Disorders

Cellenkos Announces First Patient Dosed with CK0803 Cell Therapy for Treatment of Amyotrophic Lateral Sclerosis (PRNewswire) - "Cellenkos® Inc...announced today that it has dosed the first patient in a Phase 1/1b study evaluating CK0803 for treatment of amyotrophic lateral sclerosis (ALS) (under National Clinical Trial registry NCT05695521)....The dosing of this first patient marks the beginning of a Phase 1 Safety Run-in Study of 6 patients, to be followed by a Phase 1b Randomized, Double Blind, Placebo Control Trial of CK0803 in an additional 60 patients with ALS. The treatment will include four weekly infusions followed by five monthly infusions."

Trial status • Amyotrophic Lateral Sclerosis • CNS Disorders

REGALS: Regulatory T Cells for Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1b | N=66 | Recruiting | Sponsor: Cellenkos, Inc. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Dec 2025 ➔ May 2026

Enrollment open • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders • CSF NfL • NEFL

REGALS: Regulatory T Cells for Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1b | N=66 | Not yet recruiting | Sponsor: Cellenkos, Inc.

New P1 trial • Amyotrophic Lateral Sclerosis • CNS Disorders • CSF NfL • NEFL

Cellenkos Receives FDA Clearance of Investigational New Drug (IND) Application for CK0803 for the Treatment of Amyotrophic Lateral Sclerosis (ALS) (PRNewswire) - “Cellenkos, Inc…today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1 safety study followed by a Phase 1b randomized, double blind, placebo control trial of CK0803, neurotrophic allogeneic Treg cells, in patients with amyotrophic lateral sclerosis (ALS). The primary objective of the upcoming Phase 1 study is to establish safety and tolerability of multiple doses of CK0803 administered intravenously in patients with ALS.”

IND • Amyotrophic Lateral Sclerosis • CNS Disorders