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NCT05241444 · ClinicalTrials.gov registry record · Phase 1
CD4^LVFOXP3 in Participants With IPEX
A Phase 1 study of IPEX, sponsored by Bacchetta, Rosa, MD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05241444: Recruiting Phase 1 study of IPEX, sponsored by Bacchetta, Rosa, MD.
NCT05241444 is a Phase 1 study of IPEX that is actively recruiting participants, run by Bacchetta, Rosa, MD. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05241444, a Phase 1 study of IPEX, is actively recruiting participants, sponsored by Bacchetta, Rosa, MD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This first-in-human, Phase 1 clinical trial will test the feasibility of the manufacturing and the safety of the administration of CD4\^LVFOXP3 in up to 30 evaluable human participants with IPEX and evaluate the impact of the CD4\^LVFOXP3 infusion on the disease.
Primary Outcome
No more than two products fail the target cell dose and established release criteria.
Conditions Studied
Interventions
- BIOLOGICAL CD4^LVFOXP3
Study Locations (1)
California
- Lucile Packard Children's Hospital - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2037-02 |
| Phase | Phase 1 |
What NCT05241444 shows while recruiting
NCT05241444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with IPEX appearing as the primary indexed condition, and to 1 intervention - of which CD4^LVFOXP3 is the first listed.
NCT05241444 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05241444 about?
NCT05241444 is a clinical study titled "CD4^LVFOXP3 in Participants With IPEX". This first-in-human, Phase 1 clinical trial will test the feasibility of the manufacturing and the safety of the administration of CD4\^LVFOXP3 in up to 30 evaluable human participants with IPEX and evaluate the impact of the CD4\^LVFOXP3 infusion on the disease.
What is the current status of trial NCT05241444?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-03-22. Estimated completion is 2037-02.
What conditions does trial NCT05241444 study?
This clinical trial studies the following conditions: IPEX.
What interventions are being tested in trial NCT05241444?
The interventions under investigation include: CD4^LVFOXP3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05241444?
This trial is sponsored by Bacchetta, Rosa, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05241444 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05241444's enrollment target sits among peer trials
30 1333rd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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