Phase 2 Crohn's Disease and Colitis Trial, Not Yet Recruiting
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
- The person joining (or their legal guardian) must sign a written consent form approved by an ethics committee before any screening begins.
- Adults aged 18 to 69 years old who weigh at least 40 kg (about 88 pounds).
- People who have been diagnosed with inflammatory bowel disease (IBD) for at least 3 months before signing the consent form, confirmed through clinical findings, endoscopy, and tissue examination.
- People whose IBD has not responded well enough to, has stopped responding to, or who could not tolerate at least one advanced IBD treatment.
- People whose IBD is currently classified as moderate to severe — for ulcerative colitis (UC), this is based on a specific scoring system called the adapted Mayo score; for Crohn's disease (CD), this is based on a scoring system called SES-CD.
- People who are expected to live for more than 6 months.
- Women who are physically capable of becoming pregnant must have a negative blood pregnancy test, agree to use highly effective contraception from the time of consent until 1 year after the treatment infusion, and provide informed consent. Men who are capable of fathering children must agree to use effective barrier contraception from consent until 1 year after infusion, and must not donate semen or sperm during the entire study.
- People diagnosed with indeterminate colitis (a form of IBD that shares features of both UC and CD) may be eligible.
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 previously received any CAR-T cell therapy, or any therapy targeting BCMA or CD19, before signing the consent form.
- People with certain other types of gut inflammation that could make it harder to evaluate the treatment's effectiveness, such as undiagnosed colitis, fulminant colitis, Hirschsprung-associated enterocolitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-related colitis, or similar conditions.
- People found to have cancerous or pre-cancerous changes on endoscopy.
- People with severely reduced function of vital organs.
- People with significantly impaired bone marrow function.
- People with active hepatitis B, hepatitis C, HIV, syphilis, or active tuberculosis.
- People with IBD-related complications that the trial doctor believes would interfere with the study.
- People who have had a significant bleeding episode within the past 30 days, as determined by the trial doctor.
- People with serious, uncontrolled bacterial, viral, or fungal infections.
- People who were hospitalised for IBD-related complications within 30 days before screening.
- People with significant brain or nervous system conditions that the trial doctor believes would make participation unsafe.
- People who have had, or currently have, another cancer diagnosis (though exceptions may be considered by the trial doctor).
- People who have received a vaccine within 30 days before screening, or who plan to be vaccinated within 3 months after the treatment infusion.
- People currently taking, or who have recently taken, another experimental drug without a sufficient washout period, as determined by the trial doctor.
- People the trial doctor considers unsuitable for the blood collection process (leukapheresis), whose disease is not compatible with receiving the treatment infusion, or who have any reason they cannot complete key trial procedures such as a colonoscopy.
- Women who are pregnant or breastfeeding.
- People with autoimmune diseases that the trial doctor believes require whole-body treatment and could affect how the trial results are evaluated.
- People the trial doctor identifies as having suicidal tendencies, or who currently use tobacco, substances, or alcohol in a way that would affect participation.
- People with a history of severe drug allergies, or who are known to be allergic to any ingredients in the trial treatment or related medications.
- People the trial doctor believes should not participate for any other medical 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.
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
Phone: 6315386218
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
Where this trial is recruiting
Primary endpoints
Number of Adverse Events (AEs) after ICG318 CAR-T infusion.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.