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Clinical Trials in China / NCT07018050
Recruiting Phase 2

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

NCT07018050 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Pharmaceutical Co., Ltd.
Phase
Phase 2
Started
2025-09-12
Last updated
2026-06-08

Condition(s) studied

Relapsed or Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

QLS32015 →Pomalidomide →Dexamethasone →QL2109 or Daratumumab →Bortezomib →Lenalidomide →

QLS32015: QLS32015 will be administered subcutaneously

Pomalidomide: Pomalidomide will be self-administered as a single dose orally

Dexamethasone: Dexamethasone will be administered orally or intravenously

QL2109 or Daratumumab: QL2109 or Daratumumab will be administered subcutaneously.

Bortezomib: Bortezomib will be administered subcutaneously

Lenalidomide: Lenalidomide will be self-administered as a single dose orally

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria; * Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy; * Measurable disease at screening, defined by at least one of the following: * Serum M-protein ≥1.0 g/dL (10 g/L); * Urine M-protein ≥200 mg/24 hours; * Serum immunoglobulin free light chain ≥10 mg/dL (100 mg/L) with an abnormal serum immunoglobulin κ/λ free light chain ratio. Exclusion Criteria: * History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy); * Prior anti-myeloma therapies within the specified timeframes before enrollment: * Previous treatment with GPRC5D-targeted therapy; * Genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T-cell \[CAR-T\], natural killer \[NK\] cell therapy) within 3 months; * Targeted therapy, investigational drugs, or invasive investigational medical devices within 21 days or 5 half-lives (whichever is longer); * Bispecific antibody therapy for multiple myeloma within 21 days or 5 half-lives (whichever is longer); * Cytotoxic therapy or monoclonal antibodies within 21 days; * Proteasome inhibitor therapy within 14 days; * Immunomodulatory drug therapy within 7 days; * Radiotherapy within 14 days (except low-dose palliative radiation \[10-30 Gy\]); * Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide); * Prior intolerance to Bortezomib (applies to treatment cohorts containing bortezomid); * Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide); * Prior intolerance to Daratumumab (applies to treatment cohorts containing Daratumumab).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology & Blood Diseases Hospital Tianjin China Recruiting

On this site

📄 Revlimid (lenalidomide) drug profile →

More Qilu Pharmaceutical Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07018050 on ClinicalTrials.gov ↗ ← All trials in China