Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06607016
PHASE2

A Clinical Trial With KJ103 in Anti-GBM Disease

Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: An 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-10-21

Completion Date

2026-03

Last Updated

2025-06-13

Healthy Volunteers

No

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.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China