Evaluation of the Tolerance, Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of MIL62 Injection for Treating Lupus Nephritis
Condition(s) studied
Investigational drug(s) / intervention(s)
Recombinant Humanized Monoclonal Antibody MIL62 Injection: Phase 1b: Intravenous infusion. Dose group 1 (500mg), dose group 2 (1000mg); administered on Day 1 of Weeks 1, 3, 25, 27, 53, 55, and 77. Dose group 3 (500mg), administered on Days 1, 2, 3, 4, 25, 26, 27, 28, 53, 54, 55, 56, 77, and 78 of each respective week. Phase 2: Use the dose and frequency determined in Phase 1b.
placebo: Phase 1b: Intravenous infusion. Dose group 1 (500mg), dose group 2 (1000mg); administered on Day 1 of Weeks 1, 3, 25, 27, 53, 55, and 77. Dose group 3 (500mg), administered on Days 1, 2, 3, 4, 25, 26, 27, 28, 53, 54, 55, 56, 77, and 78 of each respective week. Phase 2: Use the dose and frequency determined in Phase 1b.
Study summary
This study is composed of two stages: Part A is a randomized, double-blind, placebo-controlled dose-escalation study (i.e., Phase 1b study). The first part has a total of 3 dose groups, with 10 subjects enrolled in each dose group. Subjects are randomly assigned to receive MIL62 combined with standard of care or placebo combined with standard of care at a 4:1 ratio. Based on the tolerability, safety, pharmacodynamics, pharmacokinetics, and preliminary efficacy of the 3 dose groups, the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and dosing frequency will be determined.
Part B is open-label, enrolling 10 subjects who will receive the recommended dose of MIL62 combined with standard of care.
Eligibility
Primary outcome measure(s)
- Percentage of subjects achieving complete renal remission (CRR) at 76 weeks — week 76
Percentage of Participants with UPCR \< 0.3 and estimated glomerular filtration rate (eGFR) decline ≤ 15% from baseline
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
More Beijing Mabworks Biotech Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07044115 on ClinicalTrials.gov ↗ ← All trials in China