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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis

A Randomized, Controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of HLX79 (Human Sialidase Fusion Protein) in Combination With Rituximab Injection (HLX01, Anti-CD20 Antibody) Versus Placebo in Patients With Active Glomerulonephritis

A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis (NCT07038382) is a Phase 2 interventional studying Membranous Nephropathy and Lupus Nephritis (LN), sponsored by Shanghai Henlius Biotech. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis. The secondary objective are to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HLX79 and HLX01, the clinical efficacy, the dynamic changes of biomarkers of HLX79 in combination with HLX01 in the treatment of glomerulonephritis. The subjects will receive different doses of HLX79 (10, 20, or 30 mg/kg) or placebo, all in combination with HLX01. After the end of the first treatment period, subjects will enter a 20-week follow-up period and then undergo pre-second treatment period assessments. If the investigator determines that the subject does not require the second treatment period, the subject will continue in follow-up until completing the total 48-week follow-up period.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Membranous Nephropathy and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 24 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients who voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the willing to sign a consent form form (ICF), and are willing to follow and able to complete all study procedures. 2. Male or female, aged 18-75 years (both inclusive) at the time of signing the ICF. 3. Diagnosed with primary membranous nephropathy (MN) within 5 year prior to screening 4. If a diagnosis of primary MN is confirmed, a renal biopsy pathological diagnosis prior to screening or a renal biopsy diagnosis obtained during screening should be available, or patients with nephrotic syndrome and a positive anti-PLA2R antibody test within 6 months prior to screening; secondary MN (secondary to infection, tumor, SLE, drugs, etc.) should be excluded; subjects should have received treatment with angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin II receptor blocker (ARBs) at the highest tolerated dose judged by the investigator for 3 months prior to screening (unless intolerance to ACEI/ARB, contraindications to their use or a low blood pressure that could induce side effects, at the investigator's discretion) and also meet one of the following high-risk criteria: - Urine protein \> 8 g/24 h at screening.(The above 3-month ACEI/ARB treatment observation period is not required) - eGFR ≥ 60 mL/min/1.73 m2 and urine protein \> 3.5 g/24 h at screening 5. Women of childbearing potential (WOCBP) must undergo a pregnancy test at screening and obtain a negative result. 6. WOCBP or male subjects must agree to take effective contraceptive measures starting from signing the ICF until 12 months after the last dose of the investigational medicinal product (IMP). Who Should NOT Join This Trial: 1. Pregnant or lactating women, or those with a positive blood pregnancy test prior to randomization. 2. WOCBP or partners of male subjects who plan to become pregnant during the study. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients who voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the informed consent form (ICF), and are willing to follow and able to complete all study procedures. 2. Male or female, aged 18-75 years (both inclusive) at the time of signing the ICF. 3. Diagnosed with primary membranous nephropathy (MN) within 5 year prior to screening 4. If a diagnosis of primary MN is confirmed, a renal biopsy pathological diagnosis prior to screening or a renal biopsy diagnosis obtained during screening should be available, or patients with nephrotic syndrome and a positive anti-PLA2R antibody test within 6 months prior to screening; secondary MN (secondary to infection, tumor, SLE, drugs, etc.) should be excluded; subjects should have received treatment with angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin II receptor blocker (ARBs) at the highest tolerated dose judged by the investigator for 3 months prior to screening (unless intolerance to ACEI/ARB, contraindications to their use or a low blood pressure that could induce side effects, at the investigator's discretion) and also meet one of the following high-risk criteria: * Urine protein \> 8 g/24 h at screening.(The above 3-month ACEI/ARB treatment observation period is not required) * eGFR ≥ 60 mL/min/1.73 m2 and urine protein \> 3.5 g/24 h at screening 5. Women of childbearing potential (WOCBP) must undergo a pregnancy test at screening and obtain a negative result. 6. WOCBP or male subjects must agree to take effective contraceptive measures starting from signing the ICF until 12 months after the last dose of the investigational medicinal product (IMP). Exclusion Criteria: 1. Pregnant or lactating women, or those with a positive blood pregnancy test prior to randomization. 2. WOCBP or partners of male subjects who plan to become pregnant during the study. 3. History of drug or alcohol abuse within 1 year prior to screening. 4. Malignancy or increased risk of malignancy prior to screening: suspected and/or diagnosed with any malignancy (except for basal cell carcinoma, squamous cell carcinoma of skin in situ, or cervical carcinoma in situ occurring within 5 years prior to screening with no evidence of recurrence after treatment). 5. History of organ transplantation or stem cell or bone marrow transplantation prior to screening, or plan to undergo the above-mentioned transplantations during the study. 6. Complicated with primary immunodeficiency diseases, type 1 diabetes mellitus, and type 2 diabetes mellitus (Type 2 diabetic patients with a renal biopsy report within one year prior to screening that excludes diabetic nephropathy are eligible to participate in this study) before screening. 7. Presence of the following diseases that are significantly unstable or poorly controlled at screening: cardiovascular disorder, hematological disease, respiratory disorder, digestive system disorder, endocrine and metabolic system disease, nervous system disorder or psychiatric disorders, skin and subcutaneous tissue disorders, musculoskeletal system disorder, immune system disorders, or Grade 3 or greater medical abnormalities (CTCAE v5.0), and the investigator believes that the subject should be excluded due to the above diseases or abnormalities, or the investigator believes that the above diseases or abnormalities may interfere with the interpretation of the study results. 8. End-stage renal disease requiring kidney transplantation or dialysis, or oliguria (urine volume \< 400 mL/24 h) at screening or prior to randomization. 9. Acute, recurrent, or chronic infection (including but not limited to tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacterial infection) at screening, 10. Infection requiring intravenous or intramuscular injection of anti-infective drugs within 2 months prior to randomization, or infection requiring hospitalization within 2 months prior to randomization. 11. Lung CT or chest X-ray at screening suggesting tuberculosis infection or previous tuberculosis infection. 12. Abnormalities in 12-lead ECG at screening, such as corrected QT (QTc) interval \> 450 ms in males and corrected QT (QTc) interval \> 470 ms in females (Fridericia's method). 13. Abnormal results of the following laboratory tests at screening: 1. Hemoglobin \< 90 g/L, or platelet count \< 100 × 109 L, or neutrophil count \< 1.5 × 109 L. 2. Alkaline phosphatase (ALP) \> 2 × upper limit of normal (ULN), or total bilirubin (TB) \> 2 × ULN, or alanine aminotransferase (ALT) \> 2 × ULN, or aspartate aminotransferase (AST) \> 2 × ULN, or blood amylase \> 1.5 × ULN. 3. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2. 4. International normalized ratio (INR) \> 2.5 (not on anticoagulant therapy). 5. Interferon gamma release assay positive. 6. Serological test positive for human immunodeficiency virus (HIV) antibodies. 7. Test results positive for treponema pallidum (syphilis). 8. Positive for hepatitis B virus (HBV) surface antigen (HBsAg), or positive for HBV core antibody (HBcAb) and HBV deoxyribonucleic acid (HBV-DNA). 9. Hepatitis C virus (HCV) infection (HCV antibody positive with HCV-RNA \> ULN). 14. History of serious drug allergy before screening: history of allergy to two or more drugs, or history of allergy or serious side effects to HLX01, HLX79, or their excipients, or history of anaphylaxis to intravascular injection of contrast agents, human or murine proteins, or monoclonal antibodies, or history of anaphylactic shock. 15. History of or need for treatment with one of the following drugs prior to screening: * Treatment with glucocorticoids, MMF (or other forms of mycophenolate) within 1 month prior to randomization * Treatment with calcineurin inhibitors (CNIs) such as tacrolimus and cyclosporine A or other immunosuppressive agents within 3 months prior to randomization * Treatment with alkylating agents such as cyclophosphamide (CYC) and ifosfamide within 6 months prior to randomization * Subjects who still require treatment with glucocorticoids, MMF (or other forms of mycophenolate), or alkylating agents or other immunosuppressive agents during the study as judged by the investigator at screening. 16. Have received treatment with abatacept, telitacicept, JAK inhibitors, thalidomide, lenalidomide, bortezomib, cladribine, belimumab, rituximab, or other targeted drugs (T lymphocytes, B lymphocytes, interleukin-1, interleukin-6, type I interferon, etc.) within 1 year prior to randomization.Subjects who have received B-cell depleting drugs (such as rituximab) within the past year are eligible to participate in this study if there is evidence that the number of CD19+ or CD20+ B cells have recovered to the lower limit of normal or above. 17. Have received intravenous infusion of immunoglobulin or plasma exchange within 3 months prior to randomization. 18. Have participated in a clinical study of other investigational medicinal products prior to screening, with an interval between this study and the previous study being too short: within 1 month prior to the first administration of this study or within 5 half-lives of the previous investigational medicinal product (whichever is longer). Or plan to participate in clinical studies of other investigational medicinal products before completing all scheduled assessments in this clinical study. 19. Have participated in surgical or device clinical studies within 3 months prior to screening or plan to participate in other surgical or device clinical studies during this clinical study. 20. Have received any live or live attenuated vaccine within 3 months prior to screening, or plan to receive any live or live attenuated vaccine during the study. 21. Use of herbal medicines, traditional Chinese medicines, or local traditional remedies that have therapeutic effects for MN within 14 days prior to randomization. 22. Unable to establish venous access due to poor tolerability or difficulty in finding veins, or unable or unwilling to undergo repeated venipuncture. 23. Donated whole blood or blood components (more than 400 mL) or lost a large amount of blood (more than 400 mL) within 2 months prior to screening, or plan to donate whole blood or blood components during the study. 24. The investigator has a clear reason to believe that participation in this study will damage the rights and interests of the subject.

Treatments Being Tested

DRUG

HLX79 10mg/kg/Placebo+HLX01

Subjects with MN will receive HLX79 10mg/kg or placebo, combine with HLX01 375 mg/m2

DRUG

HLX79 20mg/kg/Placebo + HLX01

Subjects with MN will receive HLX79 20mg/kg or placebo combined with HLX01 375 mg/m2

DRUG

HLX79 30mg/kg/placebo+HLX01

Subjects with MN will receive HLX79 30mg/kg or placebo combined with HLX01 375 mg/m2

Locations (17)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Tsinghua Changgung Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Xiangya Hospital Of Gentral South University
Changsha, China
Guangdong Provincial People's Hospital
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, China
The Second Hospital of Anhui Medical University
Hefei, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Jiangxi Provincial People's Hospital
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
Zhongdong Hospital Southeast University
Nanjing, China
Shanghai General Hospital
Shanghai, China
Renmin Hospital Of Wuhan University
Wuhan, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, China
The First Affiliated Hospital Of Xiamen University
Xiamen, China
Su Bei People's Hospital
Yangzhou, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07038382), the sponsor (Shanghai Henlius Biotech), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07038382 clinical trial studying?

The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis. The secondary objective are to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HLX79 and HLX01, the clinical efficacy, the dynamic changes of biomarkers of HLX79 in combination with HLX01 in the treatment of glomerulonephritis. The subjects will receive different doses of HLX79 (10, 20, or 30 mg/kg) or placebo, all in combination with HLX01. After the end of… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07038382?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07038382?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07038382. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07038382. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.