NCT06721962 · Tr1X, Inc.
Treatment of Moderate to Severe Refractory Crohn's Disease
What this study is about
This research study is testing an experimental 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.
View original scientific description
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.
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and females ≥ 18 and ≤ 65 years of age at time of Screening 2. Weight of ≥ 40 kg 3. Medical history and biological evidence of active bowel inflammation documented by:
- 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 by central reader), and;
- Highly sensitive C-reactive protein (hs-CRP) \> 5 mg/L at Screening. 4. Active disease defined as moderate to severe active CD at Screening defined by all of the following:
- Evidence of mucosal inflammation, defined as SES-CD ≥ 6 (≥ 4 for subjects with isolated ileal disease), and;
- Average daily very soft or liquid stool frequency (SF) ≥ 4 and/or average daily abdominal pain (AP) score ≥ 2 (values represent the unweighted daily averages of the corresponding sub-scores from the CDAI and total scores
- 220). 5. Subject on treatment with corticosteroids m
Where
- Scottsdale, Arizona
- Sacramento, California
- San Francisco, California
- Gainesville, Florida
- Chicago, Illinois
- Iowa City, Iowa
- Louisville, Kentucky
- Ann Arbor, Michigan
- Rochester, Minnesota
- St Louis, Missouri
- New York, New York
- Cleveland, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 10, 2025 · Source of record for eligibility and locations