A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

July 19, 2022 updated by: Keymed Biosciences Co.Ltd

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

A study of CM313 in subjects with systemic lupus erythematosus

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CM313 2 mg/kg
Once 1 week, intravenous infusion.
Biological: CM313 2 mg/kg
Once 1 week, intravenous infusion.
EXPERIMENTAL: CM313 4 mg/kg
Once 1 week, intravenous infusion.
Biological: CM313 4 mg/kg
Once 1 week, intravenous infusion.
EXPERIMENTAL: CM313 8 mg/kg
Once 1 week, intravenous infusion.
Biological: CM313 8 mg/kg
Once 1 week, intravenous infusion.
EXPERIMENTAL: CM313 16 mg/kg
Once 1 week, intravenous infusion.
Biological: CM313 16 mg/kg
Once 1 week, intravenous infusion.
PLACEBO_COMPARATOR: Placebo
Once 1 week, intravenous infusion.
Biological: Placebo
Once 1 week, intravenous infusion.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 30, 2022

Primary Completion (ANTICIPATED)

October 30, 2023

Study Completion (ANTICIPATED)

October 30, 2023

Study Registration Dates

First Submitted

July 7, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (ACTUAL)

July 20, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM313-106001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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