UB-VV410 for adults with active, treatment-refractory systemic lupus and lupus nephritis

An Open-Label Clinical Study of UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis

This trial will test whether UB-VV410 is safe and how it acts in adults with active, treatment-refractory systemic lupus erythematosus, including those with lupus nephritis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Nanjing IASO Biotechnology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: tocilizumab, CAR T
• Locations: 1 site (Nanjing)
• Trial ID: NCT07109986 on ClinicalTrials.gov

What this trial studies

This open-label, investigator-initiated Phase 1 study enrolls adults with clinically active, treatment-refractory SLE and includes separate cohorts for patients with biopsy-proven active lupus nephritis and those with active non‑LN SLE. Initial dose-finding (DF) will be performed across both cohorts combined to identify the maximum tolerated or administered dose and a recommended dose. Dose expansion (DE) cohorts may then be opened separately for the LN and non-LN groups to gather preliminary efficacy, safety, pharmacokinetic, and pharmacodynamic data. Safety, tolerability, and PK/PD are the primary focus, with exploratory efficacy signals characterized during dose expansion.

Who should consider this trial

Good fit: Adults aged 18–65 with clinically active, treatment-refractory SLE meeting 2019 EULAR/ACR criteria, including those with biopsy evidence of active lupus nephritis or active non‑LN SLE, with required baseline lab values and antibody history, are ideal candidates.

Not a fit: Patients with mild or well‑controlled SLE, significant uncontrolled liver disease or coagulopathy, those outside the 18–65 age range, or those who are pregnant are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, UB-VV410 could provide a new treatment option for adults with refractory SLE and lupus nephritis who have not responded to existing therapies.

How similar studies have performed: Other biologic approaches in SLE have produced mixed results—some agents like belimumab help subsets of patients while many B‑cell targeted therapies have had variable outcomes—so UB-VV410 represents a relatively novel and early-stage approach.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 and ≤65 at time of consent.
2. Provide voluntary written informed consent.
3. 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 SLE for at least 6 months.
4. Current or history of elevated anti-dsDNA（anti-double-stranded DNA ） and/or elevated anti-Smith antibody.
5. 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 ≤ 3 × ULN for subjects with Gilbert's syndrome
6. No ongoing coagulopathies requiring periodic replacement of clotting factors (eg, fresh frozen plasma, cryoprecipitate). Note: Subjects on a stable anticoagulant regimen \> 6 months with activated partial thromboplastin time (APTT) ≤ 2.5 × ULN and international normalized ratio (INR) \> 2 and \< 3 are allowed on study.
7. No serious concomitant diseases or active/uncontrolled infections.
8. For LN-specific subjects: 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.
9. For Non-LN SLE-specific subjects: 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 Assessment Group） B organ system scores, and/or at least 1 BILAG A organ system score, including, but not limited to, cardiac (peri- or myocarditis), respiratory (pleuritis or lung involvement), vascular, hematological and musculoskeletal.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. BILAG A for neuropsychiatric SLE.
3. Any acute, severe lupus-related flare that needs immediate treatment, such as acute pericarditis, catastrophic antiphospholipid syndrome, or acute CNS lupus (eg, psychosis, seizure).
4. Diagnosis of drug-induced SLE rather than idiopathic SLE.
5. Receiving hemodialysis or peritoneal dialysis.
6. History of previous bone marrow transplantation, gene therapy, adoptive cell transfer, or any kind of CAR T-cell therapy.
7. History of or active human immunodeficiency virus (HIV) infection.
8. Active hepatitis B (HepB) or hepatitis C (HepC). Note: Subjects with negative HepB virus DNA or a negative HepC virus RNA assay for viral load quantifications are permitted. Additionally, subjects who are positive for HepB surface antigen and/or anti-HepB core antibody with a negative HepB virus DNA are eligible.
9. Allergies to supportive medications required for CAR T-cell toxicity management (eg, tocilizumab).
10. 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 immune effector cell-associated neurotoxicity syndrome (ICANS).
11. 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.
12. 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.
13. Actively receiving treatment in other interventional clinical trials. Note: continued follow-up on previous trials is allowed for survivorship, but no further investigational agents or assessments will be allowed.

Where this trial is running

Nanjing

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, China (Recruiting)

Study contacts

• Principal investigator: Huijuan Mao, Doctor — Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University
• Study coordinator: Yue Wan, Bachelor

Conditions Systemic Lupus Erythematosus; Lupus Nephritis; UB-VV410; IASO