Study of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases

Study Purpose

A Phase I/II Study of LM-305 in Patients 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 will be enrolled into the study only if they meet all of the following inclusion criteria: 1. Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure. 2. Aged ≥18 years old when sign the ICF, male or female. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1。 4. Life expectancy ≥ 6 months. 5. Subjects must show appropriate organ and marrow function in laboratory examinations.

Exclusion Criteria:

Subjects will be excluded from the study, if they meet any of the following criteria: 1. A history of other malignant tumors than multiple myeloma within 3 years prior to first dosing. 2. Subjects who have severe cardiovascular disease。 3. Use of any live attenuated vaccines within 28 da ys prior to 1st dosing of IMP. 4. Child-bearing potential female who have positive results in pregnancy test or are lactating. 5. Subject who is judged as not eligible to participate in this study by the investigator.

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.	NCT05647512
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.	LaNova Medicines Limited
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Depei Wu
Principal Investigator Affiliation	The First Affiliated Hospital of Soochow University
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.	RRMM, Other Plasma Cell Diseases

Additional Details

A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma

Arms & Interventions

Arms

Experimental: LM-305 Dose Escalation

Administered intravenously

Experimental: LM-305 Combination Expansion

LM-305 Administered intravenously Dexamethasone Orally

Interventions

Drug: - LM-305

Administered intravenously

Drug: - Dexamethasone

Administered orally

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:

Tracy Ju

TracyJu@Lanovamed.com

021-68889618

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

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