A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

Keymed Biosciences

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Systemic Lupus Erythematosus

Treatments

Biological: Placebo

Biological: CM313 8 mg/kg

Biological: CM313 2 mg/kg

Biological: CM313 16 mg/kg

Biological: CM313 4 mg/kg

Study type

Interventional

Funder types

Industry

Identifiers

NCT05465707

CM313-106001

Details and patient eligibility

About

A study of CM313 in subjects with systemic lupus erythematosus

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 5 patient groups, including a placebo group

CM313 2 mg/kg

Experimental group

Description: