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New treatment option for Systemic Lupus Erythematosus
Official title UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis
ClinicalTrials.gov ID: NCT07109986
What this study is testing
What is UB-VV410?
UB-VV410 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label investigator-initiated trial (IIT) to assess the safety, efficacy, and PK（pharmacokinetic）/PD（pharmacodynamics ） of UB-VV410 in adult subjects with clinically active treatment-refractory SLE. The study population will include subjects with active LN (as defined by evidence of active inflammation on renal biopsy, referred to as the LN cohort) and subjects with active SLE without LN (ie, non-LN SLE, referred to as the non-LN cohort).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age ≥ 18 and ≤65 at time of consent.
- Provide voluntary written informed consent.
- Documented medical records indicated SLE diagnosis or diagnosis of SLE according to the 2019 EULAR（European Alliance of Associations for...
- Current or history of elevated anti-dsDNA（anti-double-stranded DNA ） and/or elevated anti-Smith antibody.
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN（upper limit of normal）, aspartate aminotransferase (AST) ≤ 2.5 × ULN, AND total bilirubin \< 1.5 × ULN (or...
You likely can't join if
- Women who are pregnant or breastfeeding.
- BILAG A for neuropsychiatric SLE.
- Any acute, severe lupus-related flare that needs immediate treatment, such as acute pericarditis, catastrophic antiphospholipid syndrome, or acute...
- Diagnosis of drug-induced SLE rather than idiopathic SLE.
- Receiving hemodialysis or peritoneal dialysis.
- History of previous bone marrow transplantation, gene therapy, adoptive cell transfer, or any kind of CAR T-cell therapy.
See the full eligibility criteria
- Age ≥ 18 and ≤65 at time of consent.
- Provide voluntary written informed consent.
- Documented medical records indicated SLE diagnosis or diagnosis of SLE according to the 2019 EULAR（European Alliance of Associations for Rheumatology）/ACR（American College of Rheumatology） classification criteria for...
- Current or history of elevated anti-dsDNA（anti-double-stranded DNA ） and/or elevated anti-Smith antibody.
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN（upper limit of normal）, aspartate aminotransferase (AST) ≤ 2.5 × ULN, AND total bilirubin \< 1.5 × ULN (or AST, ALT, and alkaline phosphatase \< 5 × ULN, and total bilirubin ≤...
- No ongoing coagulopathies requiring periodic replacement of clotting factors (eg, fresh frozen plasma, cryoprecipitate). Note: people on a stable anticoagulant regimen \> 6 months with activated partial thromboplastin...
- No serious concomitant diseases or active/uncontrolled infections.
- For LN-specific people: Active, biopsy-proven, proliferative LN with the classification of Class III or Class IV according to the 2018 revised ISN/RPS criteria. Note: Overlapping Class V is allowed.
- For Non-LN SLE-specific people: SLEDAI-2K（Systemic Lupus Erythematosus Disease Activity Index 2000） score of ≥ 8 (including at least 4 points from non-laboratory assessments; ) and at least 2 BILAG（British Isles Lupus...
- Women who are pregnant or breastfeeding.
- BILAG A for neuropsychiatric SLE.
- Any acute, severe lupus-related flare that needs immediate treatment, such as acute pericarditis, catastrophic antiphospholipid syndrome, or acute CNS lupus (eg, psychosis, seizure).
- Diagnosis of drug-induced SLE rather than idiopathic SLE.
- Receiving hemodialysis or peritoneal dialysis.
- History of previous bone marrow transplantation, gene therapy, adoptive cell transfer, or any kind of CAR T-cell therapy.
- History of or active human immunodeficiency virus (HIV) infection.
- Active hepatitis B (HepB) or hepatitis C (HepC). Note: people with negative HepB virus DNA or a negative HepC virus RNA assay for viral load quantifications are permitted. Additionally, people who are positive for HepB...
- Allergies to supportive medications required for CAR T-cell toxicity management (eg, tocilizumab).
- Ongoing CNS diseases (eg, seizure disorder, tremor, history of cerebral vascular accident [CVA]/recurrent transient ischemic attack [TIA], cerebritis, substantial psychiatric disorder) that would preclude evaluation of...
- Serious and/or uncontrolled medical condition that, in the Investigator's judgment, would cause an unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol.
- Major surgery within 12 weeks prior to administration of UB-VV410 or plans to undergo major surgery during the trial period and whom the Investigator considers to be at unacceptable risk.
- Actively receiving treatment in other treatment clinical trials. Note: continued follow-up on previous trials is allowed for survivorship, but no further investigational agents or assessments will be allowed.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.