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

Capital Medical University

Status: Not yet enrolling

Conditions: IgG4 Related Disease

Treatments: Biological: CM310

Study type: Interventional

Funder types: Other

Identifiers

NCT05728684

YYXSSC-IIT-002

Details and patient eligibility

About

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

Full description

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CM310

Experimental group

Description:

CM310, subcutaneous

Treatment:

Biological: CM310