Aug 25, 2026 —
Cellenkos has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CK0803, an investigational cell therapy for amyotrophic lateral sclerosis (ALS). The company says it is the first regulatory T-cell (Treg) product to receive Fast Track designation for the disease.
CK0803 is an allogeneic, cord blood-derived Treg cell therapy engineered to traffic across the blood-brain and blood-spinal cord barriers toward sites of active central nervous system inflammation. Rather than targeting a single antigen, it is designed to suppress the inflammatory programs and toxic microglial activation that drive neuronal injury, while secreting interleukin-10 (IL-10) to help restore immune balance. The product is manufactured using the company’s proprietary CRANE platform, requires no HLA or ABO matching, and is administered as an outpatient intravenous infusion without conditioning chemotherapy.
In a Phase I/Ib safety run-in study, six evaluable patients received the therapy across a weekly induction and monthly consolidation schedule. Reported findings included stabilization of ALSFRS-R decline, an approximately 60% decrease in plasma neurofilament light chain (NfL), and an approximately 200% increase in plasma IL-10 — results the company believes support the proposed mechanism of action. No dose-limiting toxicity has been observed across the company’s cord blood Treg programs.
Fast Track designation is intended to facilitate development and expedite review of therapies for serious conditions with unmet medical need, enabling more frequent interaction with the FDA and the potential for rolling review. Cellenkos said it believes the biological rationale for the therapy may extend to other neuroinflammatory and neurodegenerative conditions.
