TRX103 for Moderate to Severe Refractory Crohn's Disease
This research study is looking into TRX103, an investigational product, as a potential treatment for moderate to severe Crohn's disease (CD) that hasn't responded to other treatments. You might be able to join if you are between 18 and 65 years old, weigh at least 40 kg, and have a confirmed diagnosis of Crohn's disease for at least one year with active inflammation shown by endoscopy. The main goal of this study is to check the safety and how well TRX103 works when given with a low dose of cyclophosphamide. The study plans to enroll 39 participants, but its current status is unclear.
- Study design
- This is an interventional study testing TRX103 and cyclophosphamide. It plans to enroll 39 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess safety and tolerability from baseline until 12 months after the TRX103 infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06721962
Treatment of Moderate to Severe Refractory Crohn's Disease
Recruiting
PHASE1Ages 18–65InterventionalTreatmentTr1X, Inc.
~39 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:TRX103Cyclophosphamide
At a glance
Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the safety and tolerability of TRX103 infusion in subjects with moderate to severe treatment-refractory Crohn's Disease.
Measured over From baseline until 12 months post TRX103 infusion.
Conditions
Where it's being run
13 sites across 11 statesCalifornia2
Illinois2
Arizona1
Florida1
Iowa1
Kentucky1
Michigan1
Minnesota1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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) 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;
CDAI total scores ≥ 220 5. Subject on treatment with corticosteroids may be included if they meet the following:
prednisone or equivalent dose ≤ 20 mg/day; or
budesonide ≤ 9 mg/day; or
has been on a stable dose for at least 7 days prior to TRX103 dose. 6. Advanced therapy-refractory disease defined by:
TNF-alpha inhibitors
IL-12/23 inhibitors
Anti-integrins
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.
Primary failure is defined as:
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.
A response is defined as CDAI score that reduces by ≥ 100-point from Baseline or by Physician assessment.
Secondary failure, or relapse defined as:
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.
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.
Intolerant to therapy, defined as:
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. 7. Absence of uncontrolled bacterial, viral, or fungal infection at time of enrollment. 8. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.
Exclusion
active diverticulitis,
active fistulae or abscess,
abscess (abdominal or perianal) - abscess with no evidence of pus when pressed upon are permitted,
impassable fibrotic strictures - Patients with strictures passable by dilation are permitted,
symptomatic bowel strictures - must be confirmed via endoscopy and/or radiologically,
fulminant colitis,
toxic megacolon,
ostomy or ileoanal pouch - previous temporary ostomy pouch, followed by a reversal is permitted,
diagnosed with short gut or short bowel syndrome,
or any other manifestation that might require surgery while enrolled in the study. 11. 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. 12. 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). 13. Screening laboratory and other analyses show any of the following abnormal results:
Serum aspartate transaminase or alanine transaminase \> 3.0 × upper limit of normal;
Total white blood cell count \< 2,000/μL;
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;
Hemoglobin \< 8 g/dL;
Bilirubin ≥ 2 x ULN;
Platelet count \< 100,000/μL;
Absolute neutrophil count \< 1,200/μL;
Absolute lymphocytes count \< 750/μL. 14. Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction. 15. 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:
places the subject at increased risk during participation in the study, and/or;
interferes with the subject's capacity to provide informed consent and their participation in the study, and/or;
interferes with the interpretation of the results.
What this trial measures
- To assess the safety and tolerability of TRX103 infusion in subjects with moderate to severe treatment-refractory Crohn's Disease.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.