Crohns Disease
TRX103 Dose-Escalation Study for Treatment-Refractory Crohn’s Disease
This open-label study is investigating the safety and preliminary effects of escalating TRX103 doses in adults with moderate-to-severe Crohn’s disease that has not responded to at least two advanced approved therapies.
Registry title: Treatment of Moderate to Severe Refractory Crohn's Disease
13 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–65 Years
- Treatment
- TRX103 or Cyclophosphamide
- Design
- Non Randomized
- Central study contact
- Tr1X Clinical Trials Tr1X Clinical Trials858-283-7879Tr1xClinicalTrials@Tr1x.bio
- Sponsor
- Tr1X, Inc.
Research question
How safe and tolerable are escalating doses of TRX103, and what preliminary effects are observed in people with moderate-to-severe treatment-refractory Crohn’s disease?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 65 who weigh at least 40 kilograms.
- The study is looking for people with Crohn’s disease diagnosed for approximately one year or longer and confirmed by endoscopy.
- The study is looking for people with moderate-to-severe active Crohn’s disease documented by specified endoscopic and Crohn’s Disease Activity Index scores at screening.
- The study is looking for people whose Crohn’s disease did not respond to, lost response to, or could not tolerate at least two advanced approved therapies.
- Recruiting locations are listed in several U.S. states, including Arizona, California, Florida, Illinois, Iowa, Kentucky, Michigan, Minnesota, Missouri, New York, and Ohio.
Participation overview
What participation may involve
Participants receive a TRX103 infusion at a cohort-specific dose. Participants in Cohorts 2A and 3A also receive low-dose cyclophosphamide conditioning. The study assesses safety, Crohn’s disease activity, inflammation, quality of life, TRX103 kinetics, and tissue findings. What participation may involve: - Receive a TRX103 infusion at the dose assigned to the participant’s cohort. - Participants in Cohorts 2A and 3A receive low-dose cyclophosphamide conditioning. - Undergo safety monitoring for adverse events, serious adverse events, Crohn’s disease flares, and infections. - Complete assessments of endoscopic disease activity, clinical disease activity, inflammatory markers, quality of life, TRX103 kinetics, and tissue inflammation or damage. The registry describes a 12-month study period and reports measurements through 12 months after the TRX103 infusion.
Study interventions
What participants may receive or do
- TRX103: TRX103 is the investigational biological product given in different dose-level cohorts by infusion.
- Cyclophosphamide: Low-dose cyclophosphamide is used as conditioning in Cohorts 2A and 3A; the record does not further describe the conditioning schedule.
Study design
How the comparison works
This phase 1/2a study places participants sequentially into experimental cohorts receiving escalating TRX103 dose levels; two cohorts also receive low-dose cyclophosphamide conditioning. The study is non-randomized, so the registry does not describe assignment by chance. The study is open-label with no masking reported. No separate control or comparator arm is listed; all five cohorts are labeled experimental. No placebo intervention or placebo arm is listed in the registry record.
Reported activities
Procedures and tests
- TRX103 infusion.
- Low-dose cyclophosphamide conditioning for Cohorts 2A and 3A.
- Monitoring for treatment-emergent adverse events, serious adverse events, Crohn’s disease flares, and bacterial, fungal, or viral infections.
- Replication-competent lentivirus testing at approximately 3, 6, and 12 months.
- Endoscopic assessment using the Simple Endoscopic Score for Crohn’s Disease, including central review at Week 12.
- Crohn’s Disease Activity Index assessments.
- Stool testing for fecal calprotectin.
- Highly sensitive C-reactive protein testing.
- Inflammatory Bowel Disease Questionnaire and EuroQol 5-Dimension 5-Level quality-of-life questionnaires.
- Measurements of TRX103 kinetics after infusion.
- Histopathology scoring of inflammation and mucosal damage.
- Screening may involve confirming endoscopic disease activity, infection status, blood counts, liver function, kidney function, and pregnancy-related criteria.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 65 years old when they consent.
- Participants must weigh at least 40 kilograms.
- Crohn’s disease must have been diagnosed for approximately one year or longer and confirmed through endoscopy.
- Screening must show endoscopic evidence of active Crohn’s disease: Simple Endoscopic Score for Crohn’s Disease of at least 6 for ileocolonic disease or at least 4 for isolated ileal disease.
- The Crohn’s Disease Activity Index score must be at least 220 at screening.
- Participants must have failed at least two advanced approved therapies because of non-response, complete loss of response, or intolerance at an indicated Crohn’s disease dose.
- Participants taking corticosteroids may be included only under the listed dose or stability limits: prednisone-equivalent dose no more than 20 mg/day, budesonide no more than 9 mg/day, or a stable dose for at least seven days before TRX103.
- There must be no uncontrolled bacterial, viral, or fungal infection at enrollment.
Possible reasons someone may not be able to join
- A prior organ transplant or allogeneic bone marrow, peripheral blood, or cord-blood stem-cell transplant is exclusionary, with the stated exception for qualifying older blood transfusions.
- Another investigational agent or therapy within 28 days before the planned TRX103 infusion, or within five half-lives if longer, is exclusionary, as is not recovering from related toxicities.
- Approved Crohn’s disease treatment received within the protocol’s designated washout period is exclusionary, but the registry does not give the treatment-specific periods.
- Strictures, active fistulas, or abscess identified by computed tomography, magnetic resonance enterography, or endoscopy within six months of screening may exclude someone.
- Positive HIV testing, specified hepatitis B or C findings, active or recurring infections, or untreated latent tuberculosis are exclusionary, subject to the stated hepatitis B exception.
- Ulcerative colitis, indeterminate colitis, or Crohn’s disease isolated to the colon is exclusionary; the Crohn’s disease must involve the ileum, with or without the colon.
- Several Crohn’s disease complications or anatomical conditions may exclude someone, including active diverticulitis, active fistulas or abscess, impassable or symptomatic strictures, fulminant colitis, toxic megacolon, a current ostomy or ileoanal pouch, short-bowel syndrome, or a manifestation likely to require surgery during the study; listed exceptions apply.
- Bowel resection within three months before screening or a history of more than two bowel resections is exclusionary, subject to the stated ostomy and reconnection exceptions.
- Pregnancy, breastfeeding, or plans to become pregnant during the 12-month study period are exclusionary; male and female participants must agree to highly effective contraception.
- Specified abnormal screening results for liver function, blood counts, kidney function, bilirubin, platelets, neutrophils, or lymphocytes are exclusionary.
Important unknowns
What the record does not make clear
- The registry does not state the number, frequency, length, or location of study visits.
- The record gives limited corticosteroid dose and stability rules but does not clearly state which Crohn’s disease treatments may continue during the study.
- The record refers to protocol-designated washout periods for approved Crohn’s disease treatments but does not report the treatment-specific intervals.
- The registry does not explain what treatment is available if Crohn’s disease worsens during the study.
- Endoscopic eligibility and Week 12 endoscopic outcomes are described, but the complete endoscopy schedule and biopsy requirements are not.
- The registry does not say which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry lists U.S. study sites but does not describe reimbursement or support for transportation, lodging, or meals.
- The registry does not state whether any follow-up visits or assessments may be completed remotely or locally.
- The registry does not describe access to TRX103 after study participation ends.
Before contacting the site
Questions for the study team
- Which TRX103 dose cohort is currently enrolling at my preferred site, and could that cohort include cyclophosphamide conditioning?
- What is the complete schedule for screening, infusion, follow-up visits, laboratory tests, endoscopies, and biopsies?
- Which current Crohn’s disease medicines must be stopped, what washout applies to each one, and which medicines may continue?
- What conditioning does low-dose cyclophosphamide involve, including its dose, timing, monitoring, and expected short- and long-term risks?
- What treatment is available if Crohn’s disease worsens or a serious flare occurs during follow-up?
- Which study-related costs are covered, and are compensation or travel, lodging, meal, and parking support available?
- Can any follow-up assessments be completed remotely or at a medical facility closer to home?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and what risks could come from changing or pausing my current treatment for this study?
- What approved treatment alternatives remain appropriate given my prior responses, loss of response, or treatment intolerance?
- Do my disease location, strictures, fistulas, abscess history, surgeries, or other complications raise concerns about study participation?
- How should my regular gastroenterology care and flare management be coordinated with the research team during the 12-month study period?
- What risks of TRX103 infusion or cyclophosphamide conditioning are especially relevant to my infections, laboratory results, fertility plans, and other medical conditions?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Please see our study website at https://www.cdclinicaltrial.com
Study design and administration
- Organization
- Tr1X, Inc.
- Organization class
- Industry
- Organization study ID
- TRX103-02
- Lead sponsor
- Tr1X, Inc.
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Sequential
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Cohort 1
Dose level 1
Interventions: Biological: TRX103
Experimental
Cohort 2
Dose level 2
Interventions: Biological: TRX103
Experimental
Cohort 2A
Dose level 2 with conditioning
Interventions: Biological: TRX103, Drug: Cyclophosphamide
Experimental
Cohort 3
Dose level 3
Interventions: Biological: TRX103
Experimental
Cohort 3A
Dose level 3 with conditioning
Interventions: Biological: TRX103, Drug: Cyclophosphamide
Interventions
Biological
TRX103
TRX103 is an investigational research product that may treat and provide long term relief to individuals suffering from Crohn's Disease.
Drug
Cyclophosphamide
Low dose cyclophosphamide conditioning.
Eligibility
18 Years–65 Years
All
Not accepted
Inclusion criteria (27)
- Male and females ≥ 18 and ≤ 65 years of age at time of consent.Registry-derived · unreviewed
- Weight of ≥ 40 kg.Registry-derived · unreviewed
- Medical history and biological evidence of active bowel inflammation documented by:Registry-derived · unreviewed
- Minimum of approximate 1 year of Crohn's disease diagnosis confirmed through Endoscopy, and;Registry-derived · unreviewed
- 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)Registry-derived · unreviewed
- Active disease defined as moderate to severe active CD at Screening defined by all of the following:Registry-derived · unreviewed
- Evidence of mucosal inflammation, defined as SES-CD ≥ 6 (≥ 4 for subjects with isolated ileal disease), and;Registry-derived · unreviewed
- CDAI total scores ≥ 220Registry-derived · unreviewed
- Subject on treatment with corticosteroids may be included if they meet the following:Registry-derived · unreviewed
- prednisone or equivalent dose ≤ 20 mg/day; orRegistry-derived · unreviewed
- budesonide ≤ 9 mg/day; orRegistry-derived · unreviewed
- has been on a stable dose for at least 7 days prior to TRX103 dose.Registry-derived · unreviewed
- Advanced therapy-refractory disease defined by:Registry-derived · unreviewed
- TNF-alpha inhibitorsRegistry-derived · unreviewed
- IL-12/23 inhibitorsRegistry-derived · unreviewed
- Anti-integrinsRegistry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Primary failure is defined as:Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- A response is defined as CDAI score that reduces by ≥ 100-point from Baseline or by Physician assessment.Registry-derived · unreviewed
- Secondary failure, or relapse defined as:Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Intolerant to therapy, defined as:Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Absence of uncontrolled bacterial, viral, or fungal infection at time of enrollment.Registry-derived · unreviewed
- Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.Registry-derived · unreviewed
Exclusion criteria (36)
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Received any approved treatment for CD within the designated washout period (including off-label use of approved therapies) as per the protocol.Registry-derived · unreviewed
- Strictures, active fistulae (including perianal), or abscess by computed tomography (CT) or magnetic resonance enterography (MRE) or Endoscopy within 6 months of Screening.Registry-derived · unreviewed
- Positive serology for HIV.Registry-derived · unreviewed
- Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.Registry-derived · unreviewed
- Hepatitis C virus (HCV RNA detectable in any subject with anti-HCV antibodies).Registry-derived · unreviewed
- Subject with active or chronic recurring infections or untreated latent Tuberculosis (TB).Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
- Subjects with the following known complications of Crohn's DiseaseRegistry-derived · unreviewed
- active diverticulitis,Registry-derived · unreviewed
- active fistulae or abscess,Registry-derived · unreviewed
- abscess (abdominal or perianal) - abscess with no evidence of pus when pressed upon are permitted,Registry-derived · unreviewed
- impassable fibrotic strictures - Patients with strictures passable by dilation are permitted,Registry-derived · unreviewed
- symptomatic bowel strictures - must be confirmed via endoscopy and/or radiologically,Registry-derived · unreviewed
- fulminant colitis,Registry-derived · unreviewed
- toxic megacolon,Registry-derived · unreviewed
- ostomy or ileoanal pouch - previous temporary ostomy pouch, followed by a reversal is permitted,Registry-derived · unreviewed
- diagnosed with short gut or short bowel syndrome,Registry-derived · unreviewed
- or any other manifestation that might require surgery while enrolled in the study.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
- Screening laboratory and other analyses show any of the following abnormal results:Registry-derived · unreviewed
- Serum aspartate transaminase or alanine transaminase \> 3.0 × upper limit of normal;Registry-derived · unreviewed
- Total white blood cell count \< 2,000/μL;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- Hemoglobin \< 8 g/dL;Registry-derived · unreviewed
- Bilirubin ≥ 2 x ULN;Registry-derived · unreviewed
- Platelet count \< 100,000/μL;Registry-derived · unreviewed
- Absolute neutrophil count \< 1,200/μL;Registry-derived · unreviewed
- Absolute lymphocytes count \< 750/μL.Registry-derived · unreviewed
- Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.Registry-derived · unreviewed
- 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:Registry-derived · unreviewed
- places the subject at increased risk during participation in the study, and/or;Registry-derived · unreviewed
- interferes with the subject's capacity to provide informed consent and their participation in the study, and/or;Registry-derived · unreviewed
- interferes with the interpretation of the results.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
To assess the safety and tolerability of TRX103 infusion in subjects with moderate to severe treatment-refractory Crohn's Disease.
Time frame: From baseline until 12 months post TRX103 infusion.
As measured by: * Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs), including CD flares (perforations, abscesses). * Incidence of infections, either bacterial, fungal or viral. * The safety of TRX103 determined by negative Replication Competent Lentivirus (RCL) at approximately 3-months, 6-months, and 12-months.
Secondary outcome
Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD Score).
Time frame: From baseline to Week 12 post TRX103 infusion.
Endoscopic remission defined as: \- Participants with ileocolonic or isolated ileal CD: SES-CD ≤ 4 points and no sub-score \> 1 point in any individual variable, as scored by central reviewer at Week 12. OR \- Participants with isolated ileal disease: SES-CD of 0 - 2 points, as scored by central reviewer at Week 12. Endoscopic response, defined as: Decrease in SES-CD ≥ 50% from Baseline at Week 12.
Secondary outcome
Improvement of CD status.
Time frame: From baseline to Week 12 post TRX103 infusion.
* Clinical remission, defined as CD Activity Index (CDAI) ≤ 150 at Week 12. * Clinical response, defined as ≥ 100-point reduction in CDAI score from Baseline at Week 12. * Proportion of subjects who discontinue corticosteroid use and achieve clinical remission at all subsequent timepoints, in subjects taking corticosteroids at Baseline.
Secondary outcome
Reduction in Fecal Calprotectin.
Time frame: From baseline to Week 12 post TRX103 infusion.
* Change from Baseline in fecal calprotectin at each timepoint. * Proportion of subjects with fecal calprotectin \< 250 μg/mg at Week 12 or a decrease of 50% from Baseline.
Secondary outcome
Reduction of highly sensitive C-reactive protein (hs-CRP).
Time frame: From baseline until 12 months post TRX103 infusion.
Change from Baseline in hs-CRP at each timepoint.
Secondary outcome
Improvement in Patient Reported Outcomes (PRO).
Time frame: From baseline until 12 months post TRX103 infusion.
Change from Baseline in Health-Related Quality-of-Life (HRQOL) Questionnaires scores: * Inflammatory Bowel Disease Questionnaire (IBDQ) * EuroQol Group - 5 Dimension - 5 Level (EQ-5D-5L) Questionnaire
Secondary outcome
Pharmacokinetics (PK) of TRX103.
Time frame: From baseline until 12 months post TRX103 infusion.
TRX103 kinetics post infusion.
Secondary outcome
Level of Inflammation and mucosal damage
Time frame: From baseline until 12 months post TRX103 infusion.
Change from baseline in histopathological scores by Global Histologic Disease Activity Score (GHAS) and Robarts Histopathology Index (RHI).
Recruiting locations in the United States
Mayo Clinic Arizona
RecruitingScottsdale, Arizona, 85259, United States
Study Coordinator480-301-6373Hall.Megan@mayo.edu
University of California, Davis
RecruitingSacramento, California, 95817, United States
Clinical Research Supervisor(916) 734-0753tyassear@health.ucdavis.edu
University of California, San Francisco
RecruitingSan Francisco, California, 94158, United States
Study Coordinator(415) 514-1170paige.shave@ucsf.edu
University of Florida
RecruitingGainesville, Florida, 32608, United States
Study Coordinator352-273-9483Valeria.BlancoBorges@medicine.ufl.edu
Northwestern
RecruitingChicago, Illinois, 60611, United States
Study Coordinator312-695-5878rarrieta@northwestern.edu
University of Chicago
RecruitingChicago, Illinois, 60637, United States
Clinical Trial Manager773-834-7414Kristi.Kearney@uchicagomedicine.org
University of Iowa
RecruitingIowa City, Iowa, 52242, United States
Study Coordinator319-467-4169megan-sharer@uiowa.edu
University of Louisville
RecruitingLouisville, Kentucky, 40202, United States
Study Coordinator502-852-6993Kelsey.small@louisville.edu
University of Michigan
RecruitingAnn Arbor, Michigan, 48109, United States
Clinical Trial Manager734-615-4843harrisnl@med.umich.edu
Mayo Clinic Rochester
RecruitingRochester, Minnesota, 55905, United States
Study Coordinator507-266-4728IBDRESEARCH@mayo.edu
Washington University in St. Louis
RecruitingSt Louis, Missouri, 63110, United States
Study Coordinator314-273-0301luluhuang@wustl.edu
Mount Sinai Health Systems
RecruitingNew York, New York, 10029, United States
Study Coordinator(929) 641-0917Phyu.mar@mssm.edu
Cleveland Clinic
RecruitingCleveland, Ohio, 44195, United States
Study Coordinator440-523-8503dussanl@ccf.org
Central study contacts
Registry dates
- First posted
- Dec 6, 2024
- Primary completion
- Jan 30, 2026
- Overall completion
- Jan 30, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.