Actively Recruiting
UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis
Led by Nanjing IASO Biotechnology Co., Ltd. · Updated on 2026-01-23
21
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
Sponsors
N
Nanjing IASO Biotechnology Co., Ltd.
Lead Sponsor
T
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years at time of consent
- Provide voluntary written informed consent
- Diagnosis of SLE for at least 6 months according to 2019 classification criteria
- Current or history of elevated anti-double-stranded DNA and/or anti-Smith antibody
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 2.5 times upper limit of normal, and total bilirubin < 1.5 times upper limit of normal (exceptions for Gilbert's syndrome)
- No ongoing coagulopathies requiring periodic clotting factor replacement; stable anticoagulant regimen allowed
- No serious concomitant diseases or active/uncontrolled infections
- For lupus nephritis subjects: Active, biopsy-proven Class III or IV lupus nephritis (Class V overlap allowed)
- For non-lupus nephritis SLE subjects: SLEDAI-2K score ≥ 8 with specified BILAG organ system scores
You will not qualify if you...
- Women who are pregnant or breastfeeding
- BILAG A score for neuropsychiatric SLE
- Acute, severe lupus flare needing immediate treatment (e.g., acute pericarditis, catastrophic antiphospholipid syndrome, acute CNS lupus)
- Diagnosis of drug-induced SLE
- Receiving hemodialysis or peritoneal dialysis
- History of bone marrow transplantation, gene therapy, adoptive cell transfer, or CAR T-cell therapy
- History of or active HIV infection
- Active hepatitis B or C infection (with specific allowances for viral load negativity)
- Allergies to medications required for CAR T-cell toxicity management
- Ongoing CNS diseases that prevent evaluation of immune effector cell-associated neurotoxicity syndrome
- Serious or uncontrolled medical conditions posing unacceptable safety risks or interfering with study
- Major surgery within 12 weeks prior to treatment or planned during the trial with unacceptable risk
- Currently receiving treatment in other interventional clinical trials (follow-up allowed)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Actively Recruiting
Research Team
Y
Yue Wan, Bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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