RecruitingPhase 2NCT07018050

Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma

A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

160 participants

Start Date

Sep 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing QLS32015, a new drug combination therapy, in patients with multiple myeloma (a bone marrow cancer) that has come back or stopped responding to at least one prior treatment, to evaluate its effectiveness and safety. **You may be eligible if...** - You have a confirmed diagnosis of multiple myeloma - Your disease has relapsed or progressed after at least one prior treatment - You have measurable disease detectable through blood or urine tests **You may NOT be eligible if...** - You have previously experienced a severe (grade 3 or higher) cytokine release syndrome from T-cell redirecting therapies or CAR-T cell therapy - You have received GPRC5D-targeted therapy previously - You have received CAR-T cell therapy in the past 3 months - You received other myeloma treatments (monoclonal antibodies, chemotherapy, etc.) within specified timeframes before enrollment - You cannot tolerate the drug components based on prior serious reactions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQLS32015

QLS32015 will be administered subcutaneously

DRUGPomalidomide

Pomalidomide will be self-administered as a single dose orally

DRUGDexamethasone

Dexamethasone will be administered orally or intravenously

DRUGQL2109 or Daratumumab

QL2109 or Daratumumab will be administered subcutaneously.

DRUGBortezomib

Bortezomib will be administered subcutaneously

DRUGLenalidomide

Lenalidomide will be self-administered as a single dose orally


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

View Full Details on ClinicalTrials.gov

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NCT07018050


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