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NCT06721962 · ClinicalTrials.gov registry record · Phase 1
Treatment of Moderate to Severe Refractory Crohn's Disease
A Phase 1 study of Crohn's Disease, sponsored by Tr1X.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 13
- Study locations
NCT06721962: Recruiting Phase 1 study of Crohn's Disease, sponsored by Tr1X.
NCT06721962 is a Phase 1 study of Crohn's Disease that is actively recruiting participants, run by Tr1X. The registered enrollment target is 39 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (98% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06721962, a Phase 1 study of Crohn's Disease, is actively recruiting participants, sponsored by Tr1X.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 13
- Study locations
Study Summary
This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.
Primary Outcome
As measured by: * Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs), including CD flares (perforations, abscesses). * Incidence of infections, either bacterial, fungal or viral. * The safety of TRX103 determined by negative Replication Competent Lentivirus (RCL) at approximately 3-months, 6-months, and 12-months.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL TRX103
Study Locations (13)
California
- University of California, Davis - Sacramento
- University of California, San Francisco - San Francisco
Illinois
- Northwestern - Chicago
- University of Chicago - Chicago
Arizona
- Mayo Clinic Arizona - Scottsdale
Florida
- University of Florida - Gainesville
Iowa
- University of Iowa - Iowa City
Kentucky
- University of Louisville - Louisville
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2025-05-05 |
| Est. Completion | 2027-01-30 |
| Phase | Phase 1 |
What NCT06721962 shows while recruiting
NCT06721962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT06721962 lists 13 locations in 11 states (California, Illinois, Arizona).
Frequently Asked Questions
What is clinical trial NCT06721962 about?
NCT06721962 is a clinical study titled "Treatment of Moderate to Severe Refractory Crohn's Disease". This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.
What is the current status of trial NCT06721962?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2025-05-05. Estimated completion is 2027-01-30.
What conditions does trial NCT06721962 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT06721962?
The interventions under investigation include: Cyclophosphamide (DRUG), TRX103 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06721962?
This trial is sponsored by Tr1X, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06721962 being conducted?
This trial has 13 study locations across Arizona, California, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
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 NCT06721962's enrollment target sits among peer trials
39 89th of 105 higher than 17 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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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