Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07109986 | UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis | PHASE1 | RECRUITING | 21 | — | — | Oct 27, 2025 | Jul 8, 2030 | Jan 23, 2026 | 1 | China |
Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities
MTD/MAD and the recommended dose for subsequent study of UB-VV410
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| UB-VV410 | DRUG | 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. |
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） ...