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A Clinical Trial With KJ103 in Anti-GBM Disease

NCT06607016 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-06-13

No results posted yet for this study

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

Interventions

DRUG

KJ103 for Injection

Subjects will administered KJ103 intravenously on D1 and adjunctively on D8

DRUG

Cyclophosphamide

Hence treatment prevents formation of new anti-GBM antibodies.

DRUG

Glucocorticoids

Glucocorticoids inhibit the inflammation process.

PROCEDURE

Plasma exchange (PE)

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

Sponsors & Collaborators

  • Shanghai Bao Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06607016 on ClinicalTrials.gov