NCT06721962

Treatment of Moderate to Severe Refractory Crohn's Disease

A Phase 1/2a, Open Label, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of TRX103 in Subjects With Moderate to Severe Treatment-Refractory Crohn's Disease

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Tr1X, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Please see our study website at https://www.cdclinicaltrial.com

Conditions

• Crohns Disease

Interventions

Type	Name	Description
BIOLOGICAL	TRX103	TRX103 is an investigational research product that may treat and provide long term relief to individuals suffering from Crohn's Disease.
DRUG	Cyclophosphamide	Low dose cyclophosphamide conditioning.

Timeline

• Start date: 2025-05-05
• Primary completion: 2026-01-30
• Completion: 2027-01-30
• First posted: 2024-12-06
• Last updated: 2025-12-10

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study