Actively Recruiting
Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-09-22
160
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group diagnostic criteria
- Relapsed, progressed, or intolerant to at least 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 or higher, urine M-protein 200 mg/24 hours or higher, or serum immunoglobulin free light chain 10 mg/dL or higher with abnormal serum immunoglobulin kappa/lambda free light chain ratio
You will not qualify if you...
- History of Grade 3 or higher cytokine release syndrome associated with any T-cell redirecting therapy
- Previous treatment with GPRC5D-targeted therapy
- Genetically modified adoptive cell therapy within 3 months
- Targeted therapy, investigational drugs, or invasive investigational medical devices within 21 days or 5 half-lives (whichever is longer)
- Monoclonal antibodies or bispecific antibody therapy for multiple myeloma within 21 days or 5 half-lives (whichever is longer)
- Cytotoxic therapy 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 (for relevant cohorts)
- Prior intolerance to Bortezomib (for relevant cohorts)
- Prior intolerance to Lenalidomide (for relevant cohorts)
- Prior intolerance to Daratumumab (for relevant cohorts)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Actively Recruiting
Research Team
G
Gang An, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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