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

IgG4 Related Disease Clinical Trial

Official title:

A Single-arm Study Sponsored by Investigators to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Recurrent IgG4-related Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05728684
• Other study ID #: YYXSSC-IIT-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2023
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• IgG4 Related Disease

Intervention

Biological:
• CM310
CM310 Injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Response rate after administration for 12 weeks	up to week 12