A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Autoimmune D… (NCT07583030) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Autoimmune Diseases
China44 participantsStarted 2026-04-20
Plain-language summary
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory autoimmune diseases.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects voluntarily participate in clinical studies.
* Age 18-65 years.
* Adequate organ function at screening.
* Clinical laboratory values meet criteria at screening visit.
r/r SLE:
* Patients meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) OR 2012 Systemic lupus international collaborating clinics (SLICC) classification criteria for SLE at least 6 months before screening.
* At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
* Fulfill relapsed/refractory SLE conditions.
r/r IgG4-RD：
* Patients meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for IgG4-RD.
* Fulfill relapsed/refractory IgG4-RD conditions.
* Patients have active disease: IgG4-RD Response Index (RI) ≥2.
Progressive MS：
* Diagnosis of MS according to 2017 revised McDonald criteria.
* Progressive MS according to clinical course criteria revised in 2013.
* Presence of Cerebrospinal fluid (CSF) oligoclonal bands (OCBs) or elevated IgG Index at screening.
r/r MG：
* Diagnosis of MG.
* Myasthenia Gravis Foundation of America (MGFA) Class II-IV.
* Positive AChR-IgG or MuSK-IgG at screening.
* Fulfill refractory MG conditions.
Exclusion Criteria:
* Active infections such as hepatitis and tuberculosis.
* Coexist other autoimmune or inflammatory diseases.
* Severe underlying diseases such as tumor, uncontrolled di…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Early Phase 1 and hasn't even started recruiting yet — given that it's this early, what do we actually know so far about the safety profile of LVIVO-TaVec400, and how does that uncertainty weigh against my current treatment options for my condition?
2Since the study is measuring dose-limiting toxicities and finding a recommended dose regimen, which means they're still figuring out the right dose, how does that level of unknowing factor into your recommendation for whether I should consider this versus sticking with or switching to an established therapy?
3My condition is listed as one of several very different autoimmune diseases in this trial — does that mean the treatment is being tested broadly across all of them, and how might that affect what we can learn about how well it works specifically for my diagnosis?
4Because the trial isn't recruiting yet, do you have any sense of when it might open, where it will be run, and whether the logistics of participating — like travel or monitoring visits — would realistically be manageable for someone in my situation?
5Given that the primary outcomes are all focused on safety and how the drug behaves in the body rather than whether it actually reduces disease activity, how should I think about the realistic chance of personal benefit if I were eventually to enroll in something like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of Dose-limiting toxicity (DLT)
Timeframe: 28 days after LVIVO-TaVec400 infusion (Day 1)
2
The incidence, severity of Adverse events (AEs)
Timeframe: Minimum 13 weeks after LVIVO-TaVec400 infusion (Day 1)
3
The incidence, severity of Treatment-related Adverse event (TRAE)
Timeframe: Maximum 15 years after LVIVO-TaVec400 infusion (Day 1)
4
Maximum concentration (Cmax) in peripheral blood
Timeframe: Maximun 5 years after LVIVO-TaVec400 infusion (Day 1)
5
Time of maximum concentration (Tmax) in peripheral blood
Timeframe: Maximum 5 years after LVIVO-TaVec400 infusion (Day 1)
6
Area under the concentration-time curve (AUC) in peripheral blood
Timeframe: Maximum 5 years after LVIVO-TaVec400 infusion (Day 1)
7
Recommended Dose regimen finding
Timeframe: Maximum 104 weeks after LVIVO-TaVec400 infusion (Day 1)
Trial details
NCT IDNCT07583030
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology