Treatment of Moderate to Severe Refractory Crohn's Disease
ConditionCrohns Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTr1X, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Male and females ≥ 18 and ≤ 65 years of age at time of consent.
Weight of ≥ 40 kg.
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)
Disqualifiers
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.
Strictures, active fistulae (including perianal), or abscess by computed tomography (CT) or magnetic resonance enterography (MRE) or Endoscopy within 6 months of Screening.
Trial design
Treatments tested in this trial
- TRX103
- Cyclophosphamide
Treatment groups
39 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov