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RECRUITINGPHASE1/PHASE2

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

NCT06721962•Tr1X, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and females ≥ 18 and ≤ 65 years of age at time of consent.
•2. Weight of ≥ 40 kg.
•3. 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)
•4. 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
•5. Subject on treatment with corticosteroids may be included if they meet the following:
•* prednisone or equivalent dose ≤ 20 mg/day; or
+18 more criteria

Exclusion Criteria

•1. Prior organ transplant, or allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant. Note: Blood transfusion are not exclusionary if it occurred ≥ 3 years (- 3 months) of TRX103 infusion.
•2. 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.
•3. Received any approved treatment for CD within the designated washout period (including off-label use of approved therapies) as per the protocol.
•4. Strictures, active fistulae (including perianal), or abscess by computed tomography (CT) or magnetic resonance enterography (MRE) or Endoscopy within 6 months of Screening.
•5. Positive serology for HIV.
•6. Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
•7. Hepatitis C virus (HCV RNA detectable in any subject with anti-HCV antibodies).
•8. Subject with active or chronic recurring infections or untreated latent Tuberculosis (TB).
•9. 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).
•10. Subjects with the following known complications of Crohn's Disease
+26 more criteria

Locations (13)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

University of California, Davis

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Florida

Gainesville, Florida, United States

Northwestern

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Louisville

Louisville, Kentucky, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

May 5, 2025

Primary Completion Date

January 30, 2026

Completion Date

January 30, 2027

Last Updated

December 10, 2025

Enrollment

ESTIMATED participants

Conditions

Crohns Disease

Interventions

TRX103

BIOLOGICAL

Cyclophosphamide

DRUG

Contacts

Tr1X Clinical Trials Tr1X Clinical Trials

CONTACT

858-283-7879 Tr1xClinicalTrials@Tr1x.bio

Study Team

CONTACT

Tr1xClinicalTrials@Tr1x.bio

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Treatment of Moderate to Severe Refractory Crohn's Disease

Inclusion Criteria

Exclusion Criteria

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