A Clinical Trial With KJ103 in Anti-GBM Disease

NCT06607016 | Active Not Recruiting Phase 2

• 1 other identifier: SHBJ-KJ103-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, single-arm Phase II study to evaluate the preliminary efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of KJ103 in patients with anti-GBM disease.

Conditions

Anti-Glomerular Basement Membrane Disease

Outcome Measures

Primary Outcomes (1)

• Renal function

  Proportion of subjects with renal function after KJ103 administration.

  day 90, day 180

Secondary Outcomes (12)

• Adverse events

  day 180

• Proportion and number of subjects requiring PE

  day 180

• Anti-GBM antibodies

  day 180

• Immunogenicity

  day 180

• eGFR and change from baseline.

  Day28, Day60, Day90, Day120, Day150, Day180

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Drug: KJ103 for Injection; Drug: Cyclophosphamide; Drug: Glucocorticoids; Procedure: Plasma exchange (PE)

Interventions

KJ103 for Injection DRUG

Subjects will administered KJ103 intravenously on D1 and adjunctively on D8

Experimental Group

Cyclophosphamide DRUG

Hence treatment prevents formation of new anti-GBM antibodies.

Experimental Group

Glucocorticoids DRUG

Glucocorticoids inhibit the inflammation process.

Experimental Group

Plasma exchange (PE) PROCEDURE

PLEX removes the patient\'s pathogenic anti-GBM antibodies, by replacement of deficient plasma with a replacement fluid.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnant or breastfeeding at the time of screening.
• Have a serious underlying medical condition other than anti-GBM disease, such as infection, autoimmune disease, respiratory disease, cardiovascular disease, central nervous system disease, etc., that the investigator deems unsuitable for participation in this trial.

Sponsors & Collaborators

• Shanghai Bao Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Anti-Glomerular Basement Membrane Disease

Interventions

Injections; Cyclophosphamide; Glucocorticoids; Plasma Exchange

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Blood Transfusion; Biological Therapy; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 23, 2024
• Study Start: October 21, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

CN (1)