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

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).