RECRUITING

Treatment of Moderate to Severe Refractory Crohn's Disease

Conditions

Crohns Disease Tr1X RESTORE Crohns autoimmune IBD CD chronic inflammation gastrointestinal tract chronic diarrhea intestinal ulcers abdominal pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-01

Study Completion:2026-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06721962

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male and females ≥ 18 and ≤ 65 years of age at time of Screening 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 by central reader), and; * Highly sensitive C-reactive protein (hs-CRP) \> 5 mg/L at Screening. 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; * Average daily very soft or liquid stool frequency (SF) ≥ 4 and/or average daily abdominal pain (AP) score ≥ 2 (values represent the unweighted daily averages of the corresponding sub-scores from the CDAI and 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 * budesonide ≤ 9 mg/day; or * has been on a stable dose for at least 7 days prior to TRX103 dose. 6. 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 * IL-12/23 inhibitors * Anti-integrins * JAK inhibitors * OR * Non-response (primary failure), complete loss of response (secondary failure) or intolerant to therapy at a dose indicated for CD. 7. Absence of uncontrolled bacterial, viral, or fungal infection at time of enrollment. 8. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.	1. Prior organ transplant, or allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant. 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 (see Table 4). 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 * active diverticulitis, * active fistulae or abscess, * abscess (abdominal or perianal), * impassable fibrotic strictures, * symptomatic bowel strictures, * fulminant colitis, * toxic megacolon, * ostomy or ileoanal pouch, * diagnosed with short gut or short bowel syndrome, * or any other manifestation that might require surgery while enrolled in the study. 11. Subject with surgical bowel resection within the past 3 months prior to Screening, or a history of \> 2 bowel resections. 12. Subjects that are pregnant, breast feeding, or aim to become pregnant during the 12 month study period. (Subjects, males and females, must agree to use a highly effective method of contraception). 13. Screening laboratory and other analyses show any of the following abnormal results: * Serum aspartate transaminase or alanine transaminase \> 3.0 × upper limit of normal; * Total white blood cell count \< 2,000/μL; * Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula \< 40 mL/min/1.73 m2; * Hemoglobin \< 8 g/dL; * Bilirubin ≥ 2 x ULN; * Platelet count \< 100,000/μL; * Absolute neutrophil count \< 1,200/μL; * Absolute lymphocytes count \< 750/μL. 14. Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction. 15. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results, which, in the Investigator's opinion: * places the subject at increased risk during participation in the study, and/or; * interferes with the subject's capacity to provide informed consent and their participation in the study, and/or; * interferes with the interpretation of the results.

Inclusion Criteria

Exclusion Criteria

1. Male and females ≥ 18 and ≤ 65 years of age at time of Screening
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 by central reader), and;
* Highly sensitive C-reactive protein (hs-CRP) \> 5 mg/L at Screening.
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;
* Average daily very soft or liquid stool frequency (SF) ≥ 4 and/or average daily abdominal pain (AP) score ≥ 2 (values represent the unweighted daily averages of the corresponding sub-scores from the CDAI and 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
* budesonide ≤ 9 mg/day; or
* has been on a stable dose for at least 7 days prior to TRX103 dose.
6. 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
* IL-12/23 inhibitors
* Anti-integrins
* JAK inhibitors
* OR
* Non-response (primary failure), complete loss of response (secondary failure) or intolerant to therapy at a dose indicated for CD.
7. Absence of uncontrolled bacterial, viral, or fungal infection at time of enrollment.
8. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.

1. Prior organ transplant, or allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant.
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 (see Table 4).
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
* active diverticulitis,
* active fistulae or abscess,
* abscess (abdominal or perianal),
* impassable fibrotic strictures,
* symptomatic bowel strictures,
* fulminant colitis,
* toxic megacolon,
* ostomy or ileoanal pouch,
* diagnosed with short gut or short bowel syndrome,
* or any other manifestation that might require surgery while enrolled in the study.
11. Subject with surgical bowel resection within the past 3 months prior to Screening, or a history of \> 2 bowel resections.
12. Subjects that are pregnant, breast feeding, or aim to become pregnant during the 12 month study period. (Subjects, males and females, must agree to use a highly effective method of contraception).
13. Screening laboratory and other analyses show any of the following abnormal results:
* Serum aspartate transaminase or alanine transaminase \> 3.0 × upper limit of normal;
* Total white blood cell count \< 2,000/μL;
* Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula \< 40 mL/min/1.73 m2;
* Hemoglobin \< 8 g/dL;
* Bilirubin ≥ 2 x ULN;
* Platelet count \< 100,000/μL;
* Absolute neutrophil count \< 1,200/μL;
* Absolute lymphocytes count \< 750/μL.
14. Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.
15. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results, which, in the Investigator's opinion:
* places the subject at increased risk during participation in the study, and/or;
* interferes with the subject's capacity to provide informed consent and their participation in the study, and/or;
* interferes with the interpretation of the results.

Contacts and Locations

Study Contact

Tr1X Clinical Trials Tr1X Clinical Trials

CONTACT

858-283-7879

Tr1xClinicalTrials@Tr1x.bio

Marco Londei, MD

CONTACT

Tr1xClinicalTrials@Tr1x.bio

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94158

United States

University of South Florida

Tampa, Florida, 33612

United States

University of Chicago

Chicago, Illinois, 60637

United States

University of Iowa

Iowa City, Iowa, 52242

United States

University of Michigan, Ann Arbor

Ann Arbor, Michigan, 48109

United States

Washington University in St. Louis

St. Louis, Missouri, 63110

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Tr1X, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01

Study Completion Date2026-12-15

Study Record Updates

Study Start Date2025-02-01

Study Completion Date2026-12-15

Terms related to this study

Keywords Provided by Researchers

Tr1X
RESTORE
Crohns
Crohns Disease
autoimmune
IBD
CD
chronic inflammation
gastrointestinal tract
chronic diarrhea
intestinal ulcers
abdominal pain

Additional Relevant MeSH Terms

Crohns Disease