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NCT05695521 · ClinicalTrials.gov registry record · Phase 1
Regulatory T Cells for Amyotrophic Lateral Sclerosis
A Phase 1 study of Amyotrophic Lateral Sclerosis, sponsored by Cellenkos.
- Active
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 3
- Study locations
NCT05695521: Active Phase 1 study of Amyotrophic Lateral Sclerosis, sponsored by Cellenkos.
NCT05695521 is a Phase 1 study of Amyotrophic Lateral Sclerosis that is active but no longer recruiting, run by Cellenkos. The registered enrollment target is 66 participants, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05695521, a Phase 1 study of Amyotrophic Lateral Sclerosis, is active but no longer recruiting, sponsored by Cellenkos.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 3
- Study locations
Study Summary
Phase 1 Safety Run-in Study of 6 patients followed by Phase 1b Randomized, Double Blind, Placebo Control Trial of CK0803, neurotropic, allogeneic, umbilical cord blood derived T regulatory (Treg) cells in additional 60 patients with Amyotrophic Lateral Sclerosis.
Primary Outcome
TLT of CK0803 as assessed by the incidence and severity of AE and SAEs using NCI-CTCAE Version 5.0 criteria. TLT is a primary endpoint for bothe phase 1 safety run-in and phase 1b RCT part
Conditions Studied
Interventions
- BIOLOGICAL CK0803
- OTHER Excipient
Study Locations (3)
Texas
- Baylor College of Medicine - Houston
- Michael E. DeBakey Veterans Affairs Medical Center - Houston
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2023-04-03 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What the registry record for NCT05695521 still lists
NCT05695521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which CK0803 is the first listed.
NCT05695521 reports a single indexed study location in Texas, New York.
Frequently Asked Questions
What is clinical trial NCT05695521 about?
NCT05695521 is a clinical study titled "Regulatory T Cells for Amyotrophic Lateral Sclerosis". Phase 1 Safety Run-in Study of 6 patients followed by Phase 1b Randomized, Double Blind, Placebo Control Trial of CK0803, neurotropic, allogeneic, umbilical cord blood derived T regulatory (Treg) cells in additional 60 patients with Amyotrophic Lateral Sclerosis.
What is the current status of trial NCT05695521?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2023-04-03. Estimated completion is 2027-12.
What conditions does trial NCT05695521 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT05695521?
The interventions under investigation include: CK0803 (BIOLOGICAL), Excipient (OTHER).
Who is sponsoring clinical trial NCT05695521?
This trial is sponsored by Cellenkos, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05695521 being conducted?
This trial has 3 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05695521's enrollment target sits among peer trials
66 52nd of 102 higher than 51 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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