A Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma

Study Purpose

This is a multi-center, open-label, Phase 1/2 study to evaluate the safety, tolerability, Pharmacokinetics, pharmacodynamics and Preliminary Efficacy of CM313 in Subjects with Relapsed or Refractory Multiple Myeloma.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Subjects age ≥ 18 years.

- Subjects diagnosed with multiple myeloma.

- Subjects with measurable lesions.

- Women of childbearing potential with negative pregnancy testing.

- Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

Exclusion Criteria:

- Previous treatment with any anti-CD38 therapy.

- Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose.

- Positive for human immunodeficiency virus (HIV) antibodies.

- Syphilis antibody positive.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06126237
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Keymed Biosciences Co.Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma

Arms & Interventions

Arms

Experimental: CM313

CM313 injection, subcutaneous

Experimental: CM313 + concomitant medication

CM313 injection, subcutaneous

Interventions

Biological: - CM313 injection

CM313, subcutaneous injection

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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