Treatment of Moderate to Severe Refractory Crohn's Disease
NCT ID: NCT06721962
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
39 participants
INTERVENTIONAL
2025-05-05
2027-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Triple Combination Therapy in High Risk Crohn's Disease (CD)
NCT02764762
Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
NCT02531113
Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's Disease
NCT00102921
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
NCT07196722
Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease
NCT00221026
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Dose level 1
TRX103
TRX103 is an investigational research product that may treat and provide long term relief to individuals suffering from Crohn's Disease.
Cohort 2
Dose level 2
TRX103
TRX103 is an investigational research product that may treat and provide long term relief to individuals suffering from Crohn's Disease.
Cohort 2A
Dose level 2 with conditioning
TRX103
TRX103 is an investigational research product that may treat and provide long term relief to individuals suffering from Crohn's Disease.
Cyclophosphamide
Low dose cyclophosphamide conditioning.
Cohort 3
Dose level 3
TRX103
TRX103 is an investigational research product that may treat and provide long term relief to individuals suffering from Crohn's Disease.
Cohort 3A
Dose level 3 with conditioning
TRX103
TRX103 is an investigational research product that may treat and provide long term relief to individuals suffering from Crohn's Disease.
Cyclophosphamide
Low dose cyclophosphamide conditioning.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TRX103
TRX103 is an investigational research product that may treat and provide long term relief to individuals suffering from Crohn's Disease.
Cyclophosphamide
Low dose cyclophosphamide conditioning.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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 Failure of therapies are defined as either non-response (primary failure), complete loss of response (secondary failure) or intolerant to therapy at a dose indicated for CD.
* Primary failure is defined as:
* When a subject does not achieve a response after having received the induction doses of a CD approved drug per prescribing information. Induction period is defined as 12-weeks.
* A response is defined as CDAI score that reduces by ≥ 100-point from Baseline or by Physician assessment.
* Secondary failure, or relapse defined as:
* Subjects who respond to the therapy or achieves remission after an induction regimen per prescribing information, but subsequently lose response or relapses during maintenance treatment.
* Relapse is defined as an increase in the CDAI score from maintenance of ≥ 100 points and a CDAI score \> 220, and/or SES-CD score ≥ 6 (or ≥ 4 if isolated ileal disease) or by Physician assessment.
* Intolerant to therapy, defined as:
* When a subject is unable to cope with the side effects or mechanism of actions of the treatment and/or experiences unacceptable side effects when dosed at appropriate therapeutic levels.
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.
Exclusion Criteria
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
* 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,
* toxic megacolon,
* ostomy or ileoanal pouch - previous temporary ostomy pouch, followed by a reversal is permitted,
* 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. Note: Surgery for temporary use of an ostomy bag or reconnection of the gut post colostomy use is not considered exclusionary, nor considered as part of the surgical resection if during the reconnection removal of tissue is required to facilitate reattachment.
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 or by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \< 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tr1X, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Washington University in St. Louis
St Louis, Missouri, United States
Mount Sinai Health Systems
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RESTORE Study
Identifier Type: OTHER
Identifier Source: secondary_id
TRX103-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.