Actively Recruiting
A Phase 1/2a Open Label Dose Escalation Study Evaluating Safety and Preliminary Efficacy of TRX103 in Adults with Moderate to Severe Treatment-Refractory Crohn's Disease
Led by Tr1X, Inc. · Updated on 2025-12-10
39
Participants Needed
13
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an investigational product called TRX103 for adults with moderate to severe Crohn's Disease that has not responded to other treatments. This study focuses on understanding how different doses of TRX103 work and how safe they are when given to individuals with this condition. The trial is sponsored by Tr1X, Inc. and includes participants aged 18 to 65 years with active bowel inflammation confirmed by medical tests. Participants will receive TRX103 in one of several dosing groups, some of which include a conditioning treatment with low dose cyclophosphamide. The study has multiple cohorts receiving different dose levels, including dose levels 1, 2, and 3, with or without conditioning. The treatment is given as an infusion, and the study is open-label, meaning both participants and researchers know which treatment is given. The goal is to find the best dose that balances safety and preliminary effectiveness. Throughout the study, participants will have regular assessments including endoscopic examinations to measure bowel inflammation, blood and stool tests to evaluate biomarkers of disease activity, and patient-reported outcomes to track symptoms and quality of life. Safety and tolerability of TRX103 will be closely monitored from baseline up to one year after infusion. The total participation involves multiple visits over this period to collect data on the treatment's impact and side effects.
CONDITIONS
Brief Title
Treatment of Moderate to Severe Refractory Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults aged 18 to 65 years at time of consent
- Weight of at least 40 kg
- Diagnosis of Crohn's Disease confirmed by endoscopy for at least one year
- Endoscopic evidence of active disease at screening with SES-CD score ≥6 for ilealcolonic or ≥4 for isolated ileal disease
- Moderate to severe active Crohn's Disease with CDAI score ≥220
- Stable use of corticosteroids allowed if dose is prednisone ≤20 mg/day, budesonide ≤9 mg/day, or stable for 7 days prior to TRX103 dose
- Failure of two or more advanced approved therapies for Crohn's Disease, including TNF-alpha inhibitors, IL-12/23 inhibitors, anti-integrins, or JAK inhibitors
- No uncontrolled bacterial, viral, or fungal infection at enrollment
- Ability to understand and sign informed consent and complete all study procedures and visits
You will not qualify if you...
- Prior organ transplant or allogeneic stem cell transplant; blood transfusions allowed if more than 3 years prior
- Use of another investigational agent within 28 days or unresolved treatment toxicities
- Use of any approved Crohn's Disease treatment during required washout period
- Presence of strictures, active fistulae, or abscesses detected by imaging or endoscopy within 6 months
- Positive tests for HIV, active hepatitis B or C infection
- Active or untreated latent tuberculosis
- Diagnosis of ulcerative colitis, indeterminate colitis, or Crohn's Disease limited to colon only
- Known Crohn's Disease complications such as active diverticulitis, abscess, impassable strictures, fulminant colitis, toxic megacolon, ostomy, short gut syndrome, or conditions requiring surgery during study
- Surgical bowel resection within 3 months or history of more than 2 bowel resections
- Pregnancy, breastfeeding, or planning pregnancy during the study; agreement to use effective contraception
- Abnormal laboratory values including elevated liver enzymes, low blood cell counts, reduced kidney function, or anemia
- Significant heart, lung, liver, or kidney dysfunction or treatment for cardiac issues
- Serious or uncontrolled illness, psychiatric condition, active infection, or other medical conditions posing risk or interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months post TRX103 infusion
Participants receive TRX103 infusions with or without low dose cyclophosphamide conditioning depending on their cohort assignment.
Multiple visits during treatment and follow-up
Duration - Up to 12 months post TRX103 infusion
Participants are monitored for safety, treatment effects, and disease status after infusion.
Regular visits for assessments during follow-up
Trial Site Locations
Total: 13 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
4
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
5
Northwestern
Chicago, Illinois, United States, 60611
Actively Recruiting
6
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
7
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
9
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
12
Mount Sinai Health Systems
New York, New York, United States, 10029
Actively Recruiting
13
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
T
Tr1X Clinical Trials Tr1X Clinical Trials
S
Study Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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