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A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

K

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:
Once 1 week, intravenous infusion.
Treatment:
Biological: CM313 2 mg/kg
CM313 4 mg/kg
Experimental group
Description:
Once 1 week, intravenous infusion.
Treatment:
Biological: CM313 4 mg/kg
CM313 8 mg/kg
Experimental group
Description:
Once 1 week, intravenous infusion.
Treatment:
Biological: CM313 8 mg/kg
CM313 16 mg/kg
Experimental group
Description:
Once 1 week, intravenous infusion.
Treatment:
Biological: CM313 16 mg/kg
Placebo
Placebo Comparator group
Description:
Once 1 week, intravenous infusion.
Treatment:
Biological: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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