Early Phase 1 Multiple Sclerosis 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
- People who are able to understand what the study involves, are willing to take part voluntarily, and can sign a written consent form.
- People aged 18 to 65 years old.
- People who have been diagnosed with relapsing-remitting multiple sclerosis (MS), secondary progressive MS, or primary progressive MS, based on the 2017 McDonald diagnostic criteria (confirm with trial site for full diagnostic details).
- People whose MS disability level, measured by a standard scale called the EDSS, falls between 2.5 and 6.5 at the screening stage.
- People who weigh at least 45 kg and have a body mass index (BMI) of 18.0 kg/m² or higher.
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 a history of seizures or epilepsy, although a history of fever-related seizures in childhood is generally permitted.
- People who have had a known MS relapse (a flare-up of neurological symptoms followed by partial or full recovery) within the 8 weeks before enrolling.
- People who have had a neurological condition other than MS — such as a head injury, stroke-related condition, or vascular dementia — within the past 3 months.
- People who have had a serious infection (such as pneumonia or blood infection) within the 4 weeks before screening, or who needed hospitalisation or intravenous medications for an infection in that period, or who have an ongoing chronic bacterial infection (such as tuberculosis) that the trial doctor considers unacceptable.
- People with severe cognitive difficulties, a mental health condition, another degenerative brain condition (such as Parkinson's disease or Alzheimer's disease), a history of substance misuse, or any other condition that the trial doctor believes would interfere with the study or make participation unsafe.
- People who have attempted suicide or had significant suicidal thoughts (rated Grade 4 or 5 on a standard assessment scale) in the 24 weeks before screening, or who are considered at risk of suicide by the trial doctor.
- People who have an unstable or serious heart, lung, cancer, liver, or kidney condition — or another significant medical condition unrelated to MS — that would make safe participation in the trial not possible.
- People who received a live vaccine within 14 days before the screening visit, or who are expected to receive a vaccine during the study period.
- People who are HIV-positive.
- People whose blood test results at screening fall outside acceptable ranges, including certain liver enzyme levels, bilirubin levels (unless a specific inherited liver condition called Gilbert syndrome applies), low albumin levels, or reduced kidney function, as well as any other blood test or heart tracing (ECG) results the trial doctor considers clinically significant.
- People who test positive for hepatitis B surface antigen or a specific hepatitis B antibody at screening or within the 12 weeks before starting the study drug, unless test results clearly indicate a past resolved infection or vaccination response.
- People who test positive for hepatitis C antibodies at screening or within 12 weeks before starting the study drug, unless a confirmed negative hepatitis C RNA test shows the infection has fully cleared.
- People who have used immune-modifying monoclonal antibody treatments or other study drugs within 3 months or 5 half-lives before the screening period, whichever is the longer timeframe.
- People who are known to be allergic to any ingredient in the study drug or any other NK cell injection treatment.
- People who tested positive for hepatitis B or C and received a live or weakened vaccine within 6 weeks before the baseline visit.
- People who cannot have an MRI scan due to a pacemaker, metal implants in high-risk areas of the body (such as prosthetic heart valves or aneurysm clips), metal fragments in high-risk areas (such as shrapnel), a known allergy to gadolinium contrast dye, or claustrophobia that would prevent completion of all required MRI scans as set out in the study protocol. (Note: people with a contraindication to gadolinium dye may still be considered, but gadolinium would not be used in their scans — confirm with trial site.)
- People with a current or past diagnosis of a primary immune deficiency condition.
- People who are currently pregnant or breastfeeding, or who plan to become pregnant during the study or within 12 months after the last dose; this criterion also applies to people with severe psychiatric disorders who would not be able to attend follow-up appointments (confirm with trial site).
- People currently taking any of the following MS medications: aminopyridine/dalfampridine, fingolimod, cladribine, siponimod, ponesimod, ozanimod, alemtuzumab, mitoxantrone, ocrelizumab, natalizumab, or similar approved medications for MS under different brand names, any unapproved MS treatment, or any new MS disease-modifying therapy approved after July 2022.
- People whom the trial doctor considers unsuitable for any other reason not listed above.
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
Principal Investigator: Yong Zhang, MD, The Affiliated Hospital of Xuzhou Medical University
Phone: +86 18052268193
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
Primary endpoints
Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.