Printed from Voxsanity (voxsanity.com.au) — NCT07523100 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Multiple Sclerosis Trial, Not Yet Recruiting
NCT07523100
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
- Adults aged 18 to 65 years (inclusive), of any gender.
- People diagnosed with multiple sclerosis (MS) who currently have no effective treatment options — specifically those diagnosed with progressive MS (primary or secondary progressive) or relapsing-remitting MS (RRMS) according to the 2024 McDonald diagnostic criteria, and who have a disability score (EDSS) between 2 and 7 at the time of screening.
- RRMS patients must also meet at least one of the following: they have tried at least one MS disease-modifying therapy that did not work well enough; they have had at least 2 relapses in the past 2 years, or 1 relapse plus at least one new active lesion on MRI in the past 2 years, or at least one new active lesion on MRI in the past 6 months; or at least 2 active lesions visible on a brain MRI scan at the time of screening.
- Bone marrow function must meet minimum thresholds: a neutrophil count of at least 1×10⁹/L (without recent use of colony-stimulating factor medications) and a haemoglobin level of at least 60g/L.
- Liver function must be within acceptable ranges: ALT and AST each no more than 3 times the upper limit of normal, and total bilirubin no more than 1.5 times the upper limit of normal.
- Kidney function must show a creatinine clearance rate of at least 30 ml/minute (calculated using the Cockcroft/Gault formula).
- Blood clotting function must be within acceptable ranges: INR and prothrombin time each no more than 1.5 times the upper limit of normal.
- Heart function must show good haemodynamic stability (confirm with trial site).
- Women of childbearing age and their male partners, and men whose partners are of childbearing age, must agree to use medically approved contraception or abstain from sexual activity during the study treatment and for at least 12 months after treatment ends; women of childbearing age must have a negative pregnancy blood test within 7 days before joining and must not be breastfeeding.
- People who are willing to participate voluntarily, sign an informed consent form, and commit to attending all required follow-up appointments.
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 recently used immunosuppressant medications — specifically within five half-lives of those drugs, or within 4 weeks of biological therapies; people who have received rituximab within the past 3 months (unless B-cell counts have recovered).
- People with a history of severe drug allergies or who are known to have a generally allergy-prone constitution.
- People with active infections (such as fungal, bacterial, or viral infections) that are uncontrolled or currently require treatment.
- People with active tuberculosis at the time of screening.
- People with significant heart dysfunction (classified above Grade II on the NYHA scale) that would prevent them from tolerating the study's cell collection and reinfusion procedures.
- People with a condition where the immune system cannot produce enough antibodies from birth (congenital immunoglobulin deficiency).
- People who have had a malignant tumour (cancer) that has not been in full remission within the past five years.
- People with end-stage kidney failure.
- People who test positive for hepatitis B surface antigen, hepatitis B core antibody with detectable HBV DNA, hepatitis C antibody with detectable HCV RNA, HIV antibody, or syphilis.
- People who are pregnant, or who plan to become pregnant or father a child during the study or within 2 years after receiving the study treatment.
- People who the trial researchers determine have other reasons that make participation unsuitable (confirm with trial site).
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.
Contact this trial
Phone: 13607178809
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Daishi Tian
Registry
ClinicalTrials.gov
Start date
7 April 2026
Est. completion
1 April 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Dose Limiting Toxicity; The types, severity and frequency of adverse events (AE)
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.
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.