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A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

CM313 2 mg/kg

CM313 4 mg/kg

CM313 8 mg/kg

CM313 16 mg/kg

Placebo

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

CM313 2 mg/kg

CM313 4 mg/kg

CM313 8 mg/kg

CM313 16 mg/kg

Placebo

Arm Description

Once 1 week, intravenous infusion.

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs).

Safety parameters

Secondary Outcome Measures

Full Information

NCT ID

NCT05465707

First Posted

July 7, 2022

Last Updated

July 19, 2022

Sponsor

Keymed Biosciences Co.Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05465707

Brief Title

A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 30, 2022 (Anticipated)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Keymed Biosciences Co.Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CM313 2 mg/kg

Arm Type

Experimental

Arm Description

Once 1 week, intravenous infusion.

Arm Title

CM313 4 mg/kg

Arm Type

Experimental

Arm Description

Once 1 week, intravenous infusion.

Arm Title

CM313 8 mg/kg

Arm Type

Experimental

Arm Description

Once 1 week, intravenous infusion.

Arm Title

CM313 16 mg/kg

Arm Type

Experimental

Arm Description

Once 1 week, intravenous infusion.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Once 1 week, intravenous infusion.

Intervention Type

Biological

Intervention Name(s)

CM313 2 mg/kg

Intervention Description

Once 1 week, intravenous infusion.

Intervention Type

Biological

Intervention Name(s)

CM313 4 mg/kg

Intervention Description

Once 1 week, intravenous infusion.

Intervention Type

Biological

Intervention Name(s)

CM313 8 mg/kg

Intervention Description

Once 1 week, intravenous infusion.

Intervention Type

Biological

Intervention Name(s)

CM313 16 mg/kg

Intervention Description

Once 1 week, intravenous infusion.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Once 1 week, intravenous infusion.

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events (TEAEs).

Description

Safety parameters

Time Frame

Baseline up to Day 113

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

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