Suspended

KJ103 for Anti-Glomerular Basement Membrane Disease

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What is being tested

KJ103 for Injection

+ Cyclophosphamide

+ Glucocorticoids

DrugProcedure
Who is being recruted

Urogenital Diseases+11

+ Autoimmune Diseases

+ Female Urogenital Diseases and Pregnancy Complications

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorShanghai Bao Pharmaceuticals Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 21, 2024

Actual date on which the first participant was enrolled.

Anti-glomerular basement membrane (GBM) disease is a serious and rare autoimmune condition where the body's immune system mistakenly attacks the kidneys and sometimes the lungs. This can lead to severe kidney damage or lung bleeding if not treated promptly. The current treatments involve a combination of medications to suppress the immune system and a procedure called plasma exchange to remove harmful antibodies from the blood. However, these treatments do not always work effectively, and there's a high risk of severe kidney damage or death. This study aims to explore how a new treatment, KJ103, could help manage this disease better by assessing its effectiveness and safety. In this study, patients diagnosed with anti-GBM disease will receive KJ103 treatment. The study will involve a small group of 9 to 12 participants, and it's designed as an open-label trial, meaning both researchers and participants know what treatment is being given. The treatment's impact will be monitored by measuring how well it controls the disease and its effect on the body's immune response. Researchers will also closely watch for any side effects to ensure the treatment's safety. By measuring these factors, the study hopes to determine if KJ103 can be a more effective treatment option for those suffering from this severe condition.

Official TitleAn Open-Label, Single-Arm Phase II Clinical Trial to Evaluate the Initial Efficacy, Safety, Pharmacokinetics, Pharmacodynamics and Immunogenicity of KJ103 for the Treatment of Patients With Anti-Glomerular Basement Membrane Disease
NCT06607016
Principal SponsorShanghai Bao Pharmaceuticals Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAutoimmune DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisImmune System DiseasesKidney DiseasesLung DiseasesNephritisRespiratory Tract DiseasesUrologic DiseasesLung Diseases, InterstitialAnti-Glomerular Basement Membrane DiseaseFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
Patients aged ≥18 years, both sexes.
Diagnosed with anti-GBM disease. Positive anti-GBM antibodies at screening, with or without ANCA antibody positivity.
With or without symptoms of haematuria and proteinuria.
Patients of childbearing potential who do not plan to have children during the study and for 6 months after the end of the study, or who are using effective contraception during sexual intercourse.
6 exclusion criteria prevent from participating
Anuria for more than 24 hours prior to the first dose.
Diagnosis of anti-GBM disease more than 14 days prior to first dose.
Moderate to severe pulmonary haemorrhage requiring mechanical ventilation during the screening period, including those occurring within two weeks prior to signing the informed consent form.
Severe renal disease not caused by anti-GBM disease, such as lupus nephritis, which, in the opinion of the investigator, makes them unsuitable for participation in this study.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
KJ103 +SOC(SoC consists of a standardized combination of PE, Cyclophosphamide, and glucocorticoids)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Peking University First Hospital

Beijing, ChinaOpen Peking University First Hospital in Google Maps
SuspendedOne Study Center