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Membranous NephropathyPhase 2NCT07038382

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 Phase 2 study of Membranous Nephropathy and Lupus Nephritis (LN), run by Shanghai Henlius Biotech at 17 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Membranous Nephropathy, Lupus Nephritis (LN)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
17 sitesChina
Study dates
5 Aug 2025to May 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Male or female, aged 18-75 years (both inclusive) at the time of signing the ICF.
  • Diagnosed with primary membranous nephropathy (MN) within 5 year prior to screening
  • 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
  • Women of childbearing potential (WOCBP) must undergo a pregnancy test at screening and obtain a negative result.
  • 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 cannot join

  • Pregnant or lactating women, or those with a positive blood pregnancy test prior to randomization.
  • WOCBP or partners of male subjects who plan to become pregnant during the study.
  • History of drug or alcohol abuse within 1 year prior to screening.
  • 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).
  • 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.
  • 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.
Show all 37Show fewer
  • 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.
  • End-stage renal disease requiring kidney transplantation or dialysis, or oliguria (urine volume < 400 mL/24 h) at screening or prior to randomization.
  • Acute, recurrent, or chronic infection (including but not limited to tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacterial infection) at screening,
  • 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.
  • Lung CT or chest X-ray at screening suggesting tuberculosis infection or previous tuberculosis infection.
  • 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).
  • Abnormal results of the following laboratory tests at screening:
  • Hemoglobin < 90 g/L, or platelet count < 100 × 109 L, or neutrophil count < 1.5 × 109 L.
  • 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.
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
  • International normalized ratio (INR) > 2.5 (not on anticoagulant therapy).
  • Interferon gamma release assay positive.
  • Serological test positive for human immunodeficiency virus (HIV) antibodies.
  • Test results positive for treponema pallidum (syphilis).
  • Positive for hepatitis B virus (HBV) surface antigen (HBsAg), or positive for HBV core antibody (HBcAb) and HBV deoxyribonucleic acid (HBV-DNA).
  • Hepatitis C virus (HCV) infection (HCV antibody positive with HCV-RNA > ULN).
  • 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.
  • 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.
  • 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.
  • Have received intravenous infusion of immunoglobulin or plasma exchange within 3 months prior to randomization.
  • 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.
  • 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.
  • 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.
  • Use of herbal medicines, traditional Chinese medicines, or local traditional remedies that have therapeutic effects for MN within 14 days prior to randomization.
  • Unable to establish venous access due to poor tolerability or difficulty in finding veins, or unable or unwilling to undergo repeated venipuncture.
  • 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.
  • The investigator has a clear reason to believe that participation in this study will damage the rights and interests of the subject.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qi Jin contact

+86-15955160489

qi_jin@henlius.com

17 sites in 1 country

China17 sites, 17 recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing

    Not yet recruiting

  • Peking University People's Hospital

    Beijing

    Not yet recruiting

  • Xiangya Hospital Of Gentral South University

    Changsha

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou

    Not yet recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

    Not yet recruiting

  • The First Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou

    Not yet recruiting

  • The Second Hospital of Anhui Medical University

    Hefei

    Not yet recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang

    Not yet recruiting

  • Jiangxi Provincial People's Hospital

    Nanchang

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Not yet recruiting

  • Jiangsu Province Hospital

    Nanjing

    Not yet recruiting

  • Zhongdong Hospital Southeast University

    Nanjing

    Not yet recruiting

  • Shanghai General Hospital

    Shanghai

    Recruiting

  • Renmin Hospital Of Wuhan University

    Wuhan

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an

    Not yet recruiting

  • The First Affiliated Hospital Of Xiamen University

    Xiamen

    Not yet recruiting

  • Su Bei People's Hospital

    Yangzhou

    Not yet recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
HLX79 10mg/kg/Placebo+HLX01, HLX79 20mg/kg/Placebo + HLX01, HLX79 30mg/kg/placebo+HLX01
Medical subject headings
Glomerulonephritis, Membranous, Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX79 10mg/kg/Placebo+HLX01Drug

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

  • HLX79 20mg/kg/Placebo + HLX01Drug

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

  • HLX79 30mg/kg/placebo+HLX01Drug

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

Study groups in NCT07038382
Study groupRoleWhat they receive
Group A1ExperimentalNot described
Receives: Drug: HLX79 10mg/kg/Placebo+HLX01
Group B1ExperimentalNot described
Receives: Drug: HLX79 20mg/kg/Placebo + HLX01
Group C1ExperimentalNot described
Receives: Drug: HLX79 30mg/kg/placebo+HLX01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    Including incidence, nature, and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0, and the incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), abnormal laboratory tests, vital signs, physical examination, and 12-lead ECG

    Measured: 24 weeks

Secondary outcomes (18)

  1. Assessment of safety

    Safety: Proportion of subjects with at least one Grade 3 or greater infection-related AE in each dose group according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, and higher grades mean a worse outcome.

    Measured: 52 weeks

  2. Plasma concentrations and PK parameters of HLX79 and HLX01

    Peak concentration (Cmax, Cmax, ss)

    Measured: 52 weeks

  3. Plasma concentrations and PK parameters of HLX79 and HLX01

    Time to peak (Tmax, Tmax, ss)

    Measured: 52 weeks

  4. Plasma concentrations and PK parameters of HLX79 and HLX01

    Area under the concentration-time curve (AUC0-inf, AUC0-t, AUC0-tau, AUCss)

    Measured: 52 weeks

  5. Plasma concentrations and PK parameters of HLX79 and HLX01

    Elimination half-life (t1/2, t1/2, ss)

    Measured: 52 weeks

  6. Plasma concentrations and PK parameters of HLX79 and HLX01

    Clearance (CL, CLss)

    Measured: 52 weeks

  7. Plasma concentrations and PK parameters of HLX79 and HLX01

    Volume of distribution (Vz, Vss)

    Measured: 52 weeks

  8. Plasma concentrations and PK parameters of HLX79 and HLX01

    Accumulation ratio (Rac)

    Measured: 52 weeks

  9. PD

    Proportion of subjects with peripheral blood CD19+ B lymphocyte count ≤ 5/μL at weeks 12, 24, 36, and 52 of treatment, and proportion of subjects with peripheral blood CD20+ B lymphocyte count ≤ 1/μL at weeks 12, 24, 36, and 52 of treatment

    Measured: 52 weeks

  10. Immunogenicity evaluation

    Positive rates of anti-drug antibody (ADA) and neutralizing antibody (NAb, if applicable) for HLX79 and HLX01

    Measured: 52 weeks

  11. Assessment of clinical efficacy

    Proportion of subjects achieving complete remission (CR) or partial remission (PR) at weeks 12, 24, 36, and 52 of treatment.

    Measured: 52 weeks

  12. Assessment of clinical efficacy

    Proportion of subjects negative for anti-M-type phospholipase A2 receptor (PLA2R) antibodies at weeks 12, 24, 36, and 52 of treatment.

    Measured: 52 weeks

  13. Assessment of clinical efficacy

    Changes in anti-PLA2R antibody level from baseline at weeks 12, 24, 36, and 52 of treatment.

    Measured: 52 weeks

  14. Explore the biomarkers

    Peripheral blood B lymphocyte counts or B lymphocyte kinetics: including the depletion kinetics of B lymphocytes and their subsets (CD20+ B lymphocytes, CD19+ B lymphocytes, and memory B lymphocytes)

    Measured: 52 weeks

  15. Explore the biomarkers

    Peripheral blood B lymphocyte counts or B lymphocyte kinetics: the recovery kinetics of B lymphocytes and their subsets (e.g., CD20+ B lymphocytes, CD19+ B lymphocytes, and memory B lymphocytes).

    Measured: 52 weeks

  16. Explore the biomarkers

    Serum immunoglobulins (IgA, IgG, and IgM).

    Measured: 52 weeks

  17. Explore the biomarkers

    Serum complements (C3 and C4).

    Measured: 52 weeks

  18. Explore the biomarkers

    Urine CD163

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start5 Aug 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07038382
Sponsor's protocol ID
HLX01HLX79-GN201
Status last verified
Nov 2025
First submitted
29 May 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Membranous Nephropathy and Lupus Nephritis (LN), run by Shanghai Henlius Biotech at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qi Jin (+86-15955160489, qi_jin@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07038382.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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