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ACTIVE NOT RECRUITING
NCT05345522
PHASE2

A Study of Anti-IL-6R mAb Injection in Patients With iMCD

Sponsor: Beijing VDJBio Co., LTD.

View on ClinicalTrials.gov

Summary

This study is a single-arm, open-label, multicenter, dose-escalation clinical study. Its primary purpose is to evaluate the safety and tolerability of recombinant humanized anti-interleukin-6 receptor monoclonal antibody ( Anti-IL-6R mAb ) injection in patients with Idiopathic Multicentric Castleman's Disease ( iMCD ) and to determine the recommended dose for follow-up studies. Its secondary purpose is to evaluate the preliminary efficacy, immunogenicity and pharmacokinetic ( PK ) index, pharmacodynamic ( PD ) characteristics of Anti-IL-6R mAb injection in patients with iMCD.

Official title: A Single-arm, Open-label, Multi-center Phase Ⅱa Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-IL-6R mAb Injection in the Treatment of Patients With Idiopathic Multicentric Castleman's Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2022-04-18

Completion Date

2025-12-31

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

BIOLOGICAL

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, q2w

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, intravenous injection for 60 to 90 minutes. Every 2 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles.

BIOLOGICAL

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q2w

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, intravenous injection for 60 to 90 minutes. Every 2 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles.

BIOLOGICAL

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, q2w

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 8 mg/kg, intravenous injection for 60 to 90 minutes. Every 2 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles.

BIOLOGICAL

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4mg/kg,q3w

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 4 mg/kg, intravenous injection for 60 to 90 minutes. Every 3 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles.

BIOLOGICAL

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, q3w

Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody Injection 6 mg/kg, intravenous injection for 60 to 90 minutes. Every 3 weeks is a cycle, the first day of each cycle is administered, a total of ≥ 4 cycles.

Locations (3)

Peking Union Medical College Hospital

Beijing, China

Peking University First Hospital

Beijing, China

West China Hospital of Sichuan Hospital

Chengdu, China