Study to Evaluate the Efficacy and Safety of CM310 in Subjects With IgG4-related Disease
Not Applicable
Not yet recruiting
- Conditions
- IgG4 Related Disease
- Interventions
- Biological: CM310
- Registration Number
- NCT05728684
- Lead Sponsor
- Beijing Friendship Hospital
- Brief Summary
This study is a single-arm study initiated to evaluate the efficacy and safety of CM310 in subjects with recurrent IgG4-related disease.
- Detailed Description
This study includes three stages: screening period, treatment period and safety follow-up period.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- ≥18 years, male and female.
- With IGG4-related disease.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CM310 CM310 CM310, subcutaneous
- Primary Outcome Measures
Name Time Method Response rate up to week 12 Response rate after administration for 12 weeks
- Secondary Outcome Measures
Name Time Method