Systemic Lupus ErythematosusPhase 1NCT07109986
UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis
A Phase 1 study testing UB-VV410 in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Nanjing IASO Biotechnology Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Lupus Nephritis
- What is being tested?
- UB-VV410
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2025to 8 Jul 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 SLE for at least 6 months.
- 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 ≤ 3 × ULN for subjects with Gilbert's syndrome
- 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.
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- No serious concomitant diseases or active/uncontrolled infections.
- 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.
- 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.
Who cannot join
- 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.
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- History of or active human immunodeficiency virus (HIV) infection.
- 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.
- 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 immune effector cell-associated neurotoxicity syndrome (ICANS).
- 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 interventional clinical trials. Note: continued follow-up on previous trials is allowed for survivorship, but no further investigational agents or assessments will be allowed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Juan hui Mao, huijuanmao@126.com
About this study
Official title: An Open-Label Clinical Study of UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis
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). It is expected that the safety profile of UB-VV410 will be similar in subjects with active LN and subjects with active non-LN SLE; thus, dose finding (DF) will be conducted in the 2 subpopulation cohorts combined. Dose expansion (DE) may be conducted separately in the LN and non-LN cohorts to characterize the preliminary efficacy of UB-VV410, as well as its safety and PK/PD, in each subpopulation.
The objective of this study is to determine the MTD（maximum tolerated dose）/MAD（maximum administered dose） and the recommended dose for subsequent studies of UB-VV410 in subjects with active LN and in subjects with active non-LN SLE. The DF portion will evaluate the safety profile of UB-VV410 administered at various DLs（dose levels）. The DE portion will further optimize the dose and define the safety profile and preliminary efficacy of UB VV410. The study will use the Bayesian optimal interval (BOIN) design to allocate subjects to various DLs to minimize exposure to subtherapeutic DLs while maintaining appropriate safety parameters. DF will be initiated with UB-VV410 administered IV and starting at DL1.
Read more
During DF, additional subjects may be backfilled at DLs found to be safe per the BOIN design and with promising activity. After DF of UB-VV410 has been completed, DE with up to 14 subjects per DL within each subpopulation cohort (eg, LN and non-LN cohorts) may be implemented at DLs less than or equal to the MTD/MAD and demonstrating efficacy to further characterize the toxicity, tolerability, PK/PD, and preliminary efficacy of UB-VV410 at the selected DLs. The DE portion will further characterize product safety and preliminary efficacy in order to optimize benefit/risk. The number of DLs for DE will be determined based on the safety, activity and PK/PD data observed from DF.
In addition, some subjects may receive retreatment with UB-VV410 if there are preliminary findings suggesting incomplete improvement and acceptable safety.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis
- Being tested
- UB-VV410
- Keywords
- UB-VV410, Lupus Nephritis, Systemic Lupus Erythematosus, IASO
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-VV410Drug
Treatment with single dose of UB-VV410, intravenous injection at Day 1. Note: Subjects may receive retreatment with UB-VV410 if there are preliminary findings suggesting incomplete improvement and acceptable safety.
| Study group | Role | What they receive |
|---|---|---|
| UB-VV410（treatment group） | Experimental | Interventions: UB-VV410. Subjects will be consented and screened. Once subject eligibility is confirmed, the Investigator will be notified which dose the subject is assigned to receive. Eligible subjects will receive UB-VV410 at the assigned DL（dose level） on Study Day 1 (Day 1). Dose-limiting toxicities (DLTs) will be assessed for 28 days after UB-VV410 treatment. Safety will be assessed throughout the study. SLE/LN disease activity will be evaluated at approximately 1, 2, 3, 6, 9, 12, 18, and 24 months following UB VV410 administration. Receives: Drug: UB-VV410 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as assessed by CTCAE（Common Terminology Criteria for Adverse Events） v5.0
Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities
Measured: up to 24 months after UB-VV410 infusion
Maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended dose for subsequent study of UB-VV410
MTD/MAD and the recommended dose for subsequent study of UB-VV410
Measured: up to 24 months after UB-VV410 infusion
Secondary outcomes (4)
clinical response of SLE to UB-VV410
Systemic Lupus Erythematosus Responder Index 4 (SRI-4) response at specified timepoints
Measured: up to 24 months after UB-VV410 infusion
clinical response of SLE to UB-VV410
The proportion of subjects with low disease activity by Lupus Low Disease Activity State (LLDAS) at specified timepoints
Measured: up to 24 months after UB-VV410 infusion
clinical response of SLE to UB-VV410
The proportion of subjects in remission as measured by Definition of Remission in SLE (DORIS) remission criteria at specified timepoints
Measured: up to 24 months after UB-VV410 infusion
clinical response of LN to UB-VV410
Clinical responses at specified timepoints as evaluated by the proportions of subjects with LN who achieve complete renal response (CRR), primary efficacy renal response (PERR), and partial renal response (PRR)
Measured: up to 24 months after UB-VV410 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start27 Oct 2025
- Primary completion8 May 2028 (estimated)
- Study completion8 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Nanjing IASO Biotechnology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible subjects will receive UB-VV410
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huijuan Mao, Doctor, Principal investigator, Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109986
- Sponsor's protocol ID
- UB-VV410CI002
- Status last verified
- Jan 2026
- First submitted
- 31 Jul 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Study of UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis
- ClinicalTrials.gov ID
- NCT07109986
- Acronym / sponsor ID
- UB-VV410CI002
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis
- Keywords
- UB-VV410, Lupus Nephritis, Systemic Lupus Erythematosus, IASO
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 8 May 2028 (estimated)
- Study completion
- 8 Jul 2030 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). It is expected that the safety profile of UB-VV410 will be similar in subjects with active LN and subjects with active non-LN SLE; thus, dose finding (DF) will be conducted in the 2 subpopulation cohorts combined. Dose expansion (DE) may be conducted separately in the LN and non-LN cohorts to characterize the preliminary efficacy of UB-VV410, as well as its safety and PK/PD, in each subpopulation.
The objective of this study is to determine the MTD（maximum tolerated dose）/MAD（maximum administered dose） and the recommended dose for subsequent studies of UB-VV410 in subjects with active LN and in subjects with active non-LN SLE. The DF portion will evaluate the safety profile of UB-VV410 administered at various DLs（dose levels）. The DE portion will further optimize the dose and define the safety profile and preliminary efficacy of UB VV410. The study will use the Bayesian optimal interval (BOIN) design to allocate subjects to various DLs to minimize exposure to subtherapeutic DLs while maintaining appropriate safety parameters. DF will be initiated with UB-VV410 administered IV and starting at DL1.
During DF, additional subjects may be backfilled at DLs found to be safe per the BOIN design and with promising activity. After DF of UB-VV410 has been completed, DE with up to 14 subjects per DL within each subpopulation cohort (eg, LN and non-LN cohorts) may be implemented at DLs less than or equal to the MTD/MAD and demonstrating efficacy to further characterize the toxicity, tolerability, PK/PD, and preliminary efficacy of UB-VV410 at the selected DLs. The DE portion will further characterize product safety and preliminary efficacy in order to optimize benefit/risk. The number of DLs for DE will be determined based on the safety, activity and PK/PD data observed from DF.
In addition, some subjects may receive retreatment with UB-VV410 if there are preliminary findings suggesting incomplete improvement and acceptable safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible subjects will receive UB-VV410
| Arm | Type | Receives |
|---|---|---|
| UB-VV410（treatment group） | Experimental | Drug: UB-VV410Interventions: UB-VV410. Subjects will be consented and screened. Once subject eligibility is confirmed, the Investigator will be notified which dose the subject is assigned to receive. Eligible subjects will receive UB-VV410 at the assigned DL（dose level） on Study Day 1 (Day 1). Dose-limiting toxicities (DLTs) will be assessed for 28 days after UB-VV410 treatment. Safety will be assessed throughout the study. SLE/LN disease activity will be evaluated at approximately 1, 2, 3, 6, 9, 12, 18, and 24 months following UB VV410 administration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 SLE for at least 6 months.
- 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 ≤ 3 × ULN for subjects with Gilbert's syndrome
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UB-VV410Treatment with single dose of UB-VV410, intravenous injection at Day 1. Note: Subjects may receive retreatment with UB-VV410 if there are preliminary findings suggesting incomplete improvement and acceptable safety. | Drug | UB-VV410（treatment group） |
Primary outcome
Number of participants with adverse events as assessed by CTCAE（Common Terminology Criteria for Adverse Events） v5.0
Time frame: up to 24 months after UB-VV410 infusion
Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities
Maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended dose for subsequent study of UB-VV410
Time frame: up to 24 months after UB-VV410 infusion
MTD/MAD and the recommended dose for subsequent study of UB-VV410
4 secondary outcomes
clinical response of SLE to UB-VV410
Time frame: up to 24 months after UB-VV410 infusion
clinical response of SLE to UB-VV410
Time frame: up to 24 months after UB-VV410 infusion
clinical response of SLE to UB-VV410
Time frame: up to 24 months after UB-VV410 infusion
clinical response of LN to UB-VV410
Time frame: up to 24 months after UB-VV410 infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huijuan Mao, Doctor principal investigator
Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UB-VV410 in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Nanjing IASO Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Wan, Bachelor (+86-18896500535, yue.wan@iasobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as assessed by CTCAE（Common Terminology Criteria for Adverse Events） v5.0 (time frame: up to 24 months after UB-VV410 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.