A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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A study of CM313 in subjects with systemic lupus erythematosus

Detailed Description
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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.

Official Title
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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

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Biological: CM313 2 mg/kg
* Biological: CM313 4 mg/kg
* Biological: CM313 8 mg/kg
* Biological: CM313 16 mg/kg
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old ≤ age ≤ 65 years old. Positive autoantibody serology test at screening. Contraception. Voluntarily sign the ICF. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM313 2 mg/kg<br>Once 1 week, intravenous infusion. | Biological: CM313 2 mg/kg<br>* Once 1 week, intravenous infusion.<br>|
| Experimental: CM313 4 mg/kg<br>Once 1 week, intravenous infusion. | Biological: CM313 4 mg/kg<br>* Once 1 week, intravenous infusion.<br>|
| Experimental: CM313 8 mg/kg<br>Once 1 week, intravenous infusion. | Biological: CM313 8 mg/kg<br>* Once 1 week, intravenous infusion.<br>|
| Experimental: CM313 16 mg/kg<br>Once 1 week, intravenous infusion. | Biological: CM313 16 mg/kg<br>* Once 1 week, intravenous infusion.<br>|
| Placebo Comparator: Placebo<br>Once 1 week, intravenous infusion. | Biological: Placebo<br>* Once 1 week, intravenous infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs). | Safety parameters | Baseline up to Day 113 |