A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- NCT05465707
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- Brief Summary
A study of CM313 in subjects with systemic lupus erythematosus
- Detailed Description
This is a multi-center, randomed, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, Pharmacokinetics and preliminary anti-tumor activity.
About 40 patients who meet eligibility criteria will be randomized 4:1 to receive either CM313 or matched placebo, intravenous infusion.
The treatment period includes single dosing and multiple dosing period, in which CM313 and placebo will be adminitrated intravenously, once every 1 week.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 18 years old ≤ age ≤ 65 years old.
- Positive autoantibody serology test at screening.
- Contraception.
- Voluntarily sign the ICF.
- With central nervous system disease caused by or not caused by SLE within 8 weeks before the first dose of study drug.
- Possibly active Mycobacterium tuberculosis infection.
- With the history of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation.
- Heavy drinking in the 3 months prior to screening.
- With depression or suicidal thoughts.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs). Baseline up to Day 113 Safety parameters
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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