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
2 other identifiers
interventional
39
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2025
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2024
CompletedFirst Posted
Study publicly available on registry
December 6, 2024
CompletedStudy Start
First participant enrolled
May 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
ExpectedDecember 10, 2025
December 1, 2025
9 months
November 25, 2024
December 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of TRX103 infusion in subjects with moderate to severe treatment-refractory Crohn's Disease.
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.
From baseline until 12 months post TRX103 infusion.
Secondary Outcomes (7)
Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD Score).
From baseline to Week 12 post TRX103 infusion.
Improvement of CD status.
From baseline to Week 12 post TRX103 infusion.
Reduction in Fecal Calprotectin.
From baseline to Week 12 post TRX103 infusion.
Reduction of highly sensitive C-reactive protein (hs-CRP).
From baseline until 12 months post TRX103 infusion.
Improvement in Patient Reported Outcomes (PRO).
From baseline until 12 months post TRX103 infusion.
- +2 more secondary outcomes
Study Arms (5)
Cohort 1
EXPERIMENTALDose level 1
Cohort 2
EXPERIMENTALDose level 2
Cohort 2A
EXPERIMENTALDose level 2 with conditioning
Cohort 3
EXPERIMENTALDose level 3
Cohort 3A
EXPERIMENTALDose level 3 with conditioning
Interventions
TRX103 is an investigational research product that may treat and provide long term relief to individuals suffering from Crohn's Disease.
Eligibility Criteria
You may qualify if:
- Male and females ≥ 18 and ≤ 65 years of age at time of consent.
- Weight of ≥ 40 kg.
- Medical history and biological evidence of active bowel inflammation documented by:
- Minimum of approximate 1 year of Crohn's disease diagnosis confirmed through Endoscopy, and;
- Endoscopic evidence of CD diagnosis at least 3 months prior to and/or at Screening (SES-CD ≥ 6 for ilealcolonic or ≥ 4 isolated ileal disease by central reader)
- Active disease defined as moderate to severe active CD at Screening defined by all of the following:
- Evidence of mucosal inflammation, defined as SES-CD ≥ 6 (≥ 4 for subjects with isolated ileal disease), and;
- CDAI total scores ≥ 220
- Subject on treatment with corticosteroids may be included if they meet the following:
- prednisone or equivalent dose ≤ 20 mg/day; or
- budesonide ≤ 9 mg/day; or
- has been on a stable dose for at least 7 days prior to TRX103 dose.
- Advanced therapy-refractory disease defined by:
- Failure of two or more advanced approved therapies. Prior therapies may be inclusive of any combination of the following:
- TNF-alpha inhibitors
- +13 more criteria
You may not qualify if:
- Received another investigational agent or therapy, within 28 days of planned TRX103 infusion (or 5 half-lives, whichever is longer) and/or have not recovered from treatment related toxicities.
- Received any approved treatment for CD within the designated washout period (including off-label use of approved therapies) as per the protocol.
- Strictures, active fistulae (including perianal), or abscess by computed tomography (CT) or magnetic resonance enterography (MRE) or Endoscopy within 6 months of Screening.
- Positive serology for HIV.
- Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
- Hepatitis C virus (HCV RNA detectable in any subject with anti-HCV antibodies).
- Subject with active or chronic recurring infections or untreated latent Tuberculosis (TB).
- Current diagnosis of ulcerative colitis (UC), indeterminate colitis or CD isolated to colon only (the colitis must be related to CD and inclusive of ileal with or without colonic involvement).
- Subjects with the following known complications of Crohn's Disease
- active diverticulitis,
- active fistulae or abscess,
- abscess (abdominal or perianal) - abscess with no evidence of pus when pressed upon are permitted,
- impassable fibrotic strictures - Patients with strictures passable by dilation are permitted,
- symptomatic bowel strictures - must be confirmed via endoscopy and/or radiologically,
- fulminant colitis,
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tr1X, Inc.lead
Study Sites (13)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
University of California, Davis
Sacramento, California, 95817, United States
University of California, San Francisco
San Francisco, California, 94158, United States
University of Florida
Gainesville, Florida, 32608, United States
Northwestern
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Louisville
Louisville, Kentucky, 40202, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Mount Sinai Health Systems
New York, New York, 10029, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2024
First Posted
December 6, 2024
Study Start
May 5, 2025
Primary Completion
January 30, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
December 10, 2025
Record last verified: 2025-12