A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus
A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multiple-dose Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of CM313 Injection in Subjects With Systemic Lupus Erythematosus
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
A study of CM313 in subjects with systemic lupus erythematosus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedStudy Start
First participant enrolled
October 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedJuly 20, 2022
July 1, 2022
1 year
July 7, 2022
July 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse events (TEAEs).
Safety parameters
Baseline up to Day 113
Study Arms (5)
CM313 2 mg/kg
EXPERIMENTALOnce 1 week, intravenous infusion.
CM313 4 mg/kg
EXPERIMENTALOnce 1 week, intravenous infusion.
CM313 8 mg/kg
EXPERIMENTALOnce 1 week, intravenous infusion.
CM313 16 mg/kg
EXPERIMENTALOnce 1 week, intravenous infusion.
Placebo
PLACEBO COMPARATOROnce 1 week, intravenous infusion.
Interventions
Eligibility Criteria
You may qualify if:
- years old ≤ age ≤ 65 years old.
- Positive autoantibody serology test at screening.
- Contraception.
- Voluntarily sign the ICF.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Zhao J, Lin C, Xie Q, Shu Q, Cui Y, Luo H, Fan W, Huang A, Zhao Y, Fu Z, Xie C, Wu H, Yang N, He L, Feng P, Zhang T, Zhou H, Liu W, Hou Q, Mao X, Sun J, Chen B, Zeng X. Anti-CD38 monoclonal antibody CM313 for systemic lupus erythematosus: a randomized, double-blind, placebo-controlled phase Ib/IIa trial. Signal Transduct Target Ther. 2025 Nov 26;10(1):383. doi: 10.1038/s41392-025-02487-2.
PMID: 41290616DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2022
First Posted
July 20, 2022
Study Start
October 30, 2022
Primary Completion
October 30, 2023
Study Completion
October 30, 2023
Last Updated
July 20, 2022
Record last verified: 2022-07