Multiple Myeloma Clinical Trials

• Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic criteria

• Relapsed/refractory multiple myeloma as defined by:

• 1\) Received at least 3 prior lines of MM treatment (must include a PI, an IMiD, and an anti-CD38 antibody).

• 2）Disease progression within 12 months of the most recent anti-MM therapy; or disease progression within the past 6 months and subsequently lack response to the most recent line of therapy.

• Measurable disease at screening as defined by any of the following:

‣ Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or

⁃ Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.

• Positive expression of either BCMA or GPRC5D on bone marrow plasma cells; must be GPRC5D expression positive if previously received BCMA targeted therapy

• ECOG 0-1

• Expected life expectancy exceeds 12 weeks

• Adequate bone marrow reserve or organ function meeting the following criteria:

‣ Hemoglobin ≥ 70 g/L

⁃ Platelet count ≥ 50 × 10\^9/L

⁃ Absolute lymphocyte count ≥ 0.3×10\^9/L

⁃ Absolute neutrophil count ≥ 1.0 × 10\^9/L

⁃ Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN)

⁃ Total bilirubin ≤ 2 times ULN; except in subjects with congenital bilirubinemia (such as Gilbert syndrome, in which case the direct bilirubin ≤1.5 × ULN is required)

⁃ Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault equation).

⁃ corrected serum calcium ≤12.5 mg/dL (≤3.1 mmol/L) or free ionized calcium ≤6.5 mg/dl (≤1.6 mmol/L)

⁃ SpO2\>92% on room air

‣ Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram; no clinically meaningful pericardial effusion by ultrasound