Abstract: INFO10-TH
A Randomized, Controlled, Multicenter, Phase 2 Clinical Study Evaluating the Efficacy, Safety, and Tolerability of HLX79 Combined with a Rituximab Biosimilar in Patients with Active Glomerulonephritis
Session Information
- Informational Posters - 1
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Yu, Xueqing, Guangdong Provincial People’s Hospital, Guangzhou, China
- Peng, Li, Palleon Pharmaceuticals Inc, Waltham, Massachusetts, United States
- Cao, Lizhi, Palleon Pharmaceuticals Inc, Waltham, Massachusetts, United States
- Brunetta, Paul Gardner, Palleon Pharmaceuticals Inc, Waltham, Massachusetts, United States
- Zang, Yunna, Shanghai Henlius Biotech Inc, Shanghai, Shanghai, China
- Chen, Cong, Shanghai Henlius Biotech Inc, Shanghai, Shanghai, China
- Zeng, Xujia, Shanghai Henlius Biotech Inc, Shanghai, Shanghai, China
- Han, Lin, Shanghai Henlius Biotech Inc, Shanghai, Shanghai, China
Description
HLX79 is a first-in-class fusion protein of engineered human sialidase NEU2 and human IgG1 Fc region and cleaves sialic acids from sialoglycan. Rituximab (RTX) is recommended for treating membranous nephropathy (MN) and lupus nephritis (LN), both major causes of end-stage renal disease. Clinical value of RTX is limited by incomplete response, disease relapse, and increased risk of infections. Preclinical models demonstrate HLX79 enhances RTX-mediated B cell depletion, particularly memory B-cells due to high sialoglycan that suppress clearance. HLX79 impacts M2 macrophages associated with inflammatory fibrosis as well. Thus, combining RTX and HLX79 may be a promising therapy in MN and LN. HLX79 has shown manageable safety in a phase 1 study (NCT05259696) in patients with advanced cancers, no dose-limiting toxicity reported up to 30 mg/kg once weekly. Here we present the design of a randomized, controlled phase 2 study.
This study aims to evaluate the efficacy, safety, and tolerability of HLX79 in combination with a RTX biosimilar (HANLIKANG) in patients with active glomerulonephritis. Eligible patients include those diagnosed with primary MN or active LN within 1 year prior to screening. This study consists of two parts: Part A is a dose escalation stage planned to enroll 24 patients with active MN or LN to assess safety; Part B is a preliminary efficacy exploration stage planned to enroll 150 MN or LN patients who will be randomized in a 2:2:1:1 ratio to receive either low-dose HLX79 plus RTX, high-dose HLX79 plus RTX, HLX79 placebo plus RTX, or HLX79 placebo plus RTX placebo, along with the corresponding standard of care. The primary endpoint in Part A is safety assessments. The primary endpoints in Part B are the proportion of MN patients achieving complete or partial remission at week 24 of treatment and the proportion of LN patients achieving PERR at week 24 of treatment. With Guangdong Provincial People’s Hospital as the lead site, 17 sites in China are participating in the study, and patient enrollment has commenced.
Funding
- This study was funded by Shanghai Henlius Biotech, Inc.