Treatment of Moderate to Severe Refractory Crohn's Disease (NCT06721962) | Clinical Trial Compass
RecruitingPhase 1/2
Treatment of Moderate to Severe Refractory Crohn's Disease
United States39 participantsStarted 2025-05-05
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Active disease defined as moderate to severe active CD at Screening defined by all of the following:
. Subject on treatment with corticosteroids may be included if they meet the following:
. Advanced therapy-refractory disease defined by:
. Absence of uncontrolled bacterial, viral, or fungal infection at time of enrollment.
. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.
Exclusion criteria
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the safety and tolerability of TRX103 infusion in subjects with moderate to severe treatment-refractory Crohn's Disease.
Timeframe: From baseline until 12 months post TRX103 infusion.
. 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).