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

Study Overview
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Brief Summary
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A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

Detailed Description
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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 (RRMM)

Official Title
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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 (RRMM) and Other Plasma Cell Diseases

Conditions
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Relapsed or Refractory Multiple Myeloma, Other Plasma Cell Diseases

Intervention / Treatment
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* Drug: LM-305
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be enrolled into the study only if they meet all of the following inclusion criteria: 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. Aged ≥18 years old when sign the ICF, male or female. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1。 Life expectancy ≥ 6 months. 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: A history of other malignant tumors than multiple myeloma within 3 years prior to first dosing Subjects who have severe cardiovascular disease。 Use of any live attenuated vaccines within 28 da ys prior to 1st dosing of IMP. Child-bearing potential female who have positive results in pregnancy test or are lactating. Subject who is judged as not eligible to participate in this study by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LM-305 Dose Escalation<br>Administered intravenously | Drug: LM-305<br>* Administered intravenously<br>|
| Experimental: LM-305 Combination Expansion<br>LM-305 Administered intravenously Dexamethasone Orally | Drug: LM-305<br>* Administered intravenously<br>Drug: Dexamethasone<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicity (DLT) | DLT is defined as a toxicity (adverse event at least possibly related to LM305) occurring during the DLT observation period | Cycle 1 of each cohort. Duration of one cycle is 21 days | 
| Adverse Events (AE) and Serious Adverse Events (SAE) | The safety profile of LM-305 will be assessed by monitoring the adverse events | From signing the informed consent form (ICF) until 28 days after end of treatment (EOT) or accept other anti-cancer therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under plasma concentration vs time curve (AUC) for LM-305 | changes in AUC over time in participants with LM-305 | Up to finished cycle 5 (each cycle is 21 days) |