Product Description
Cellenkos is developing CK-0803 as a treatment for Amyotrophic Lateral Sclerosis (ALS). (Sourced from: https://cellenkosinc.com/news/index.html)
Mechanisms of Action: Cell Therapy
Novel Mechanism: No
Modality: Cell Therapy
Route of Administration: Intravenous
FDA Designation: Orphan Drug - Amyotrophic Lateral Sclerosis *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Cellenkos
Company Location: Western America
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 1
Recent & Upcoming Milestones
Highest Development Phases
Phase 1: Amyotrophic Lateral Sclerosis
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05695521 |
REGALS | P1 |
Active, not recruiting |
Amyotrophic Lateral Sclerosis |
2026-05-01 |
50% |
2025-04-12 |
Primary Endpoints|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
10/20/2025 |
News Article |
FDA Grants Orphan Drug Designation to Cellenkos' CK0803 Tregs for Treatment of Amyotrophic Lateral Sclerosis |
|
04/22/2025 |
News Article |
Cellenkos' Off-the-Shelf Treg Cell Therapy Shows Clinical Safety and Preliminary Efficacy in ALS |
|
11/07/2024 |
News Article |
Cellenkos Announces Oral Presentation at ASH Annual Meeting 2024 Highlighting Phase 1b Clinical Data of CK0804 in Myelofibrosis |
|
04/01/2024 |
News Article |
Cellenkos® enters into Sponsored Research Agreement with Icahn School of Medicine at Mount Sinai, New York. |