Study to Evaluate the Efficacy and Safety of CM310 in Subjects With IgG4-related Disease

Beijing Friendship Hospital20 enrolled

Overview

This study is a single-arm study initiated to evaluate the efficacy and safety of CM310 in subjects with recurrent IgG4-related disease.

This study includes three stages: screening period, treatment period and safety follow-up period.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

IgG4 Related Disease

Interventions

CM310BIOLOGICAL

CM310 Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥18 years, male and female. * With IGG4-related disease. Exclusion Criteria: * Inoculate live vaccine within 4 weeks before screening. * Treponema pallidum antibody positive in screening period. * Active hepatitis in screening period. * With a history of solid organ or cell transplantation within 6 months before screening. * With other medical or non-medical conditions that are not suitable for the study by the investigator.

Outcomes

Primary Outcomes

Response rate

Response rate after administration for 12 weeks

Time frame: up to week 12

Data from ClinicalTrials.gov

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