Printed from Voxsanity (voxsanity.com.au) — NCT07309744 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Crohns Disease And Colitis
Early Phase 1 Crohn's Disease and Colitis Trial, Not Yet Recruiting
NCT07309744
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who choose to take part willingly and sign the consent form agreeing to join the study.
- People aged 18 to 70 years old, of any gender.
- People whose liver function blood tests are within an acceptable range (specific limits apply; confirm with trial site), except that a condition called Gilbert's syndrome is allowed.
- People whose kidney function tests are within an acceptable range (specific limits apply; confirm with trial site).
- People whose blood count results — including white blood cells, red blood cells, platelets, and lymphocytes — are within acceptable ranges (specific limits apply; confirm with trial site).
- People whose blood clotting test results are within an acceptable range (specific limits apply; confirm with trial site).
- People whose blood oxygen level is at or above 92% while breathing normal air at rest.
- People whose heart pumping function, measured by an ultrasound of the heart, shows the heart is working at 50% or above.
- Women who could become pregnant must have a negative pregnancy test at the start of the study.
- Women who could become pregnant must agree to use highly effective contraception from at least 28 days before the start of the preparatory treatment until 12 months after receiving the study treatment; men who could father a child must agree to use effective barrier contraception from the start of preparatory treatment until 12 months after receiving the study treatment, and must not donate sperm during the trial.
For people with Ulcerative Colitis (UC), additional criteria include:
- People who have been formally diagnosed with ulcerative colitis at least 3 months before joining the study, confirmed by examination and tissue testing (or a biopsy may be done during screening if no tissue report is available).
- People with moderate to severe active ulcerative colitis, based on a standard scoring system (Mayo score of 6–12) with a bowel lining examination score of 2 or more, done within 14 days before screening.
- People whose ulcerative colitis affects a sufficient portion of the bowel, beyond the lower section of the large intestine (approximately 15 cm or more from the anal opening).
- People with long-standing or widespread ulcerative colitis (more than 8 years of extensive disease, or more than 12 years of left-sided disease) who have had a full bowel examination (colonoscopy) within the 12 months before the first screening visit (this may be done during screening).
- People with a family history of bowel cancer, a personal history of high bowel cancer risk, age over 50, or other known risk factors must have completed relevant bowel cancer screening tests (confirm with trial site).
- People who have previously tried at least one of the following treatments and either did not respond well, stopped responding, or could not tolerate it:
- Steroid medicines (such as prednisone), either showing no adequate improvement after a course of treatment, failing to reduce the dose sufficiently on at least two attempts, or experiencing significant side effects.
- Immune-suppressing medicines (such as azathioprine or 6-mercaptopurine) for at least 8 weeks with ongoing active disease, or who experienced significant side effects from these medicines.
- People who have previously tried at least two different types of advanced treatments (such as biological medicines that target inflammation, or JAK inhibitor medicines approved for ulcerative colitis) and either did not respond well, stopped responding, or could not tolerate them.
- People who are on a stable dose of certain medicines that are permitted during the study, including oral 5-aminosalicylic acid (for at least 2 weeks before the screening bowel examination) or low-dose oral steroids (for at least 2 weeks before the screening bowel examination), at the doses specified in the trial criteria.
- People who are able to stop taking other ulcerative colitis treatments (apart from the permitted medicines listed above) before the preparatory treatment phase, following the specific rules set out in the trial protocol.
- People who are willing and able to attend all scheduled study visits, including bowel examinations (endoscopies).
For people with Crohn's Disease (CD), additional criteria include:
- People who have been formally diagnosed with Crohn's disease at least 3 months before joining the study, confirmed by examination, bowel inspection, and tissue testing (or a biopsy may be done during screening if no tissue report is available).
- People with moderate to severe active Crohn's disease, based on a standard activity score of 220 or above during screening, and who also have at least one of the following: elevated inflammation marker (CRP) in blood tests; specific types of ulcers seen on bowel examination within the past 4 months; or Crohn's disease-related ulcers seen on certain imaging scans within the past 4 months (confirm with trial site for specifics).
- People with a family history of bowel cancer, a personal history of high bowel cancer risk, age over 50, or other known risk factors must have completed relevant bowel cancer monitoring tests (confirm with trial site).
- People who have previously tried at least one of the following treatments and either did not respond well, stopped responding, or could not tolerate it:
- Steroid medicines, including those who still had active disease despite adequate steroid treatment, became dependent on steroids and could not reduce the dose, or experienced significant side effects.
- Immune-suppressing medicines (such as azathioprine, 6-mercaptopurine, or methotrexate) for at least 3 months without adequate improvement, or within a monitored dose range, or who experienced significant side effects.
- People who have previously tried at least two different types of biological medicines approved for Crohn's disease and either did not respond well, stopped responding, or could not tolerate them.
- People who are on a stable dose of certain medicines permitted during the study, which may include oral 5-aminosalicylic acid, low-dose oral steroids, antibiotics specifically for Crohn's disease, probiotics, or antidiarrhoeal medicines, each at a stable dose for at least 2 weeks before the screening bowel examination (where applicable).
- People who are able to stop taking other Crohn's disease treatments (apart from the permitted medicines listed above) before the preparatory treatment phase, following the specific rules set out in the trial protocol.
- People who are willing and able to attend all planned study visits, including bowel examinations and daily diary records.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have another autoimmune disease that could significantly interfere with assessing the study disease or pose extra safety risks (though exceptions may be considered by the study team if the condition has been stable for 3 or more months).
- People with a history of severe heart failure (classified as New York Heart Association Class III or IV).
- People who have had a heart attack, heart artery procedure, stenting, unstable chest pain, or other serious heart disease within the 12 months before joining.
- People with a history of serious brain or nervous system conditions that could affect their ability to follow the study plan or affect the accuracy of assessments, such as serious brain injury, loss of consciousness, epilepsy, stroke, or brain bleeding.
- People who have had a cancer other than certain treated skin cancers or certain treated localised cancers, unless they have been free of the cancer for at least 3 years.
- People with a condition where their immune system does not work properly from birth (primary immunodeficiency).
- People with an active infection that is not under control (minor urinary tract infections or upper respiratory infections may be permitted at the study team's discretion).
- People with a known history of HIV infection, hepatitis C, or syphilis.
- People with active or latent hepatitis B infection, or who test positive for certain virus markers (Epstein-Barr virus or cytomegalovirus) at screening.
- People with a history of recurring tuberculosis or a known current tuberculosis infection.
- People who have previously received CAR-T cell therapy or any other type of genetically modified immune cell treatment.
- People who have received a live vaccine within 4 weeks before joining.
- People with a known allergy to any ingredient in the study treatment.
- People who have had a serious allergic reaction to tacrolimus (a medicine used in the study), or who have previously experienced a severe (Grade 3 or higher) toxic reaction to tacrolimus, particularly if hospitalisation was required (other cases may be considered by the study team).
- People who have taken part in another clinical trial within 30 days before screening.
- People who are pregnant or breastfeeding, or people who could become pregnant or father a child and cannot use effective contraception.
- People who need to take high-dose steroid medicines on an ongoing basis for another medical condition (apart from steroid treatment for adrenal insufficiency).
- People who test positive for a bowel infection called Clostridioides difficile (C. difficile) or other intestinal infections within 30 days before or at the time of the screening bowel examination. People who have had cytomegalovirus-related bowel inflammation must have fully completed treatment and had no symptoms for at least 3 months before the screening examination.
- People who have had lymphoma, leukaemia, or any other cancer within the past 10 years (note: certain adequately treated skin cancers or cervical in-situ cancers with no evidence of return may be exceptions — confirm with trial site).
- People with significant, uncontrolled mental health conditions, people assessed by the study doctor as being at risk of suicide, or people with a current or recent (within the past year) history of alcohol or substance dependence.
- People with serious, uncontrolled conditions affecting the heart, lungs, digestive system (other than ulcerative colitis or Crohn's disease), liver, kidneys, hormones, blood, or nervous system, which could affect safety or the ability to assess how well the treatment works.
- People with a known allergy to any ingredient of the investigational medicine.
- People whom the study doctor considers unsuitable to participate for any other reason.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Kids Helpline — 24/7, free and private for anyone aged 5 to 25: 1800 55 1800
- headspace — mental health support for 12 to 25 year olds: headspace.org.au
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Xiaohua Hou, Prof., Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phone: 027-85726057
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Early Phase 1
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Registry
ClinicalTrials.gov
Start date
20 December 2025
Est. completion
30 December 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs); Serious Adverse Events (SAEs); Adverse Events of Special Interest (AESIs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.