Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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 criteria
Qualifiers
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;
Serum M-protein ≥1.0 g/dL (10 g/L);
Urine M-protein ≥200 mg/24 hours;
Disqualifiers
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);
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);
Trial design
Treatments tested in this trial
- QLS32015
- Pomalidomide
- Dexamethasone
- QL2109 or Daratumumab
- Bortezomib
- Lenalidomide
Treatment groups
160 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov