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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05728684

Enrollment

Registered

2023-02-15

Start date

2023-02-28

Completion date

2024-02-28

Last updated

2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgG4 Related Disease

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.

Interventions

BIOLOGICALCM310

CM310 Injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Response rate	up to week 12	Response rate after administration for 12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026