Printed from Voxsanity (voxsanity.com.au) — NCT07587125 — 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, Recruiting
NCT07587125
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 aged 18 to 75 years old.
- People who are willing and able to follow the study plan, complete all required assessments, and attend follow-up appointments, and who have signed a consent form agreeing to take part.
- People who have been diagnosed with Multiple Sclerosis (MS) according to a specific set of medical guidelines (the 2017 McDonald criteria), including Primary Progressive MS (PPMS), Secondary Progressive MS (SPMS), or Relapsing-Remitting MS (RRMS).
- People whose MS has been assessed by the trial doctor as progressive or difficult to control, with no effective standard treatment available — for those with relapsing MS, this means having had at least 2 relapses in the past 2 years, or at least 1 relapse in the past year along with a specific type of lesion visible on a brain scan (MRI), despite receiving standard MS medications; people in this group must also have a disability score (called EDSS) between 2.0 and 7.0 at both the screening and baseline stages of the trial (confirm with trial site).
- Male participants who agree to use contraception during the treatment period and for at least 1 year after receiving the study treatment, and who agree not to donate sperm at any point during the study.
- Women who could become pregnant must agree to use contraception during treatment and for at least 1 year after receiving the study treatment, must have a negative blood pregnancy test at screening, and must also have a negative urine pregnancy test confirmed before receiving the study treatment for the first time.
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 any medical, psychological, or social condition that the trial doctor believes could put them at risk, affect their ability to take part, or make it difficult for them to follow the study requirements.
- Women who are pregnant or breastfeeding, who plan to become pregnant within 12 months of receiving the study treatment, or who have had a miscarriage or abortion within 4 weeks before screening.
- People who have a significant active infection (such as blood poisoning, pneumonia, or a serious abscess), or who have needed hospital treatment or intravenous antibiotics for an infection in the 4 weeks before screening; people who have a known immune deficiency condition including HIV; people who test positive for Hepatitis B, Hepatitis C with detectable virus levels, or syphilis during screening; or people with an active or high-risk history of tuberculosis.
- People who have previously received CAR-T cell therapy or any other type of genetically modified cell therapy, or who have had a bone marrow transplant or solid organ transplant; people who have received certain intravenous immune treatments (IVIG or plasma exchange) within 4 weeks before screening, or specific medications called tocilizumab or eculizumab within 3 months before screening.
- People who have an active and severe autoimmune disease other than MS (such as Lupus or Rheumatoid Arthritis); people who have another serious progressive brain or nervous system condition (such as Parkinson's disease, Alzheimer's disease, stroke, or an active brain tumour) that the trial doctor believes would make it hard to assess the MS; or people who have had an active cancer diagnosis within the past 5 years, with the exception of certain treated skin cancers or a specific type of treated cervical cell change (confirm with trial site).
- People who have certain abnormal blood test results or organ function problems during screening, including liver enzyme levels (AST or ALT) more than 1.5 times the normal upper limit, elevated bilirubin levels more than 1.5 times the normal upper limit, reduced kidney function (creatinine clearance below 60 mL/min), low white blood cell counts, low platelet counts, low haemoglobin (below 100 g/L), or serious heart or lung conditions — including a heart pumping function (LVEF) below 50%, unstable chest pain or a heart attack within the past 6 months, or a resting blood oxygen level at or below 91%.
- People who have a known severe allergy or intolerance to fludarabine, cyclophosphamide, or any ingredient in the study's CAR-T cell product (such as human serum albumin); people who have received a live vaccine within 6 weeks before screening; or people who plan to receive a live vaccine at any point during the study.
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: 86 29 84771319
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
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Trial details
Status
Recruiting
Phase
Phase 1
Sponsor
Xijing Hospital
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
1 November 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Incidence and type of Dose-Limiting Toxicities (DLTs); Incidence and severity of AEs, including changes in vital signs, physical examination, laboratory parameters, Electrocardiograms and Echocardiograms.
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.