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 range18 Years – 65 Years
SexALL
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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.
✕. Received any approved treatment for CD within the designated washout period (including off-label use of approved therapies) as per the protocol.
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.
. 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).