NCT05728684Not yet recruitingNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 20
- Primary Endpoint
- Response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
CM310
Experimental
CM310, subcutaneous
Intervention: CM310 (Biological)
Outcomes
Primary Outcomes
Response rate
Time Frame: up to week 12
Response rate after administration for 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Liu Yanying
Deputy Director of Rheumatology Department
Beijing Friendship Hospital
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