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

NCT ID: NCT05647512

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2025-12-30

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)

Conditions

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Relapsed or Refractory Multiple Myeloma Other Plasma Cell Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LM-305 Dose Escalation

Administered intravenously

Group Type EXPERIMENTAL

LM-305

Intervention Type DRUG

Administered intravenously

LM-305 Combination Expansion

LM-305 Administered intravenously Dexamethasone Orally

Group Type EXPERIMENTAL

LM-305

Intervention Type DRUG

Administered intravenously

Dexamethasone

Intervention Type DRUG

Administered orally

Interventions

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LM-305

Administered intravenously

Intervention Type DRUG

Dexamethasone

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LaNova Medicines Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Depei Wu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Other Identifiers

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LM305-01-102

Identifier Type: -

Identifier Source: org_study_id

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