Multiple Myeloma Clinical Trials

• Age ≥ 18 years, male or female;

• Confirmed diagnosis of multiple myeloma meeting at least one of the following criteria:

∙ Disease progression after at least 2 prior standard treatment regimens; or poor response to primary therapeutic agents (e.g., immunomodulatory agents, proteasome inhibitors)

‣ Disease progression within 18 months after first-line therapy

‣ Presence of features associated with high risk of disease relapse or progression (e.g., high-risk cytogenetic abnormalities);

• At least one measurable disease indicator:

∙ Serum M-protein ≥ 0.5 g/dL

‣ Urine M-protein ≥ 200 mg/24 hours

‣ Involved serum free light chain (sFLC) ≥ 10 mg/dL with an abnormal serum free light chain κ/λ ratio

• No evidence of extramedullary plasmacytoma (soft tissue plasmacytoma);

• ECOG performance status score 0-2;

• Expected survival period ≥ 3 months;

• Adequate bone marrow function within 1 month prior to screening:

∙ Hemoglobin ≥ 60 g/L;

‣ Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L;

‣ Platelet count (PLT) ≥ 50 × 10⁹/L;

‣ Lymphocyte count ≥ 0.5 × 10⁹/L;

‣ CD3-positive T-cell absolute count ≥ 0.15 × 10⁹/L;

• Adequate vital organ function within 1 month prior to screening:

∙ Renal function: creatinine clearance rate (CrCl) ≥ 30 mL/min (calculated using the Cockcroft-Gault formula), or serum creatinine (Scr) ≤ 2.0 × upper limit of normal (ULN);

‣ Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN; total bilirubin (TBIL) ≤ 2.0 × ULN (except for patients with congenital hyperbilirubinemia such as Gilbert's syndrome, in which case direct bilirubin may be ≤ 1.5 × ULN);

‣ Cardiac function: left ventricular ejection fraction (LVEF) ≥ 40%; no clinically significant pericardial effusion; and no clinically significant electrocardiogram (ECG) abnormalities (e.g., severe arrhythmia, myocardial ischemia, conduction block);

‣ Pulmonary function: blood oxygen saturation (SpO₂) ≥ 90% without supplemental oxygen;

• Women of childbearing potential must have a negative pregnancy test during the screening period and before study drug administration, and must not be lactating during the study;

⁃ Men and women of childbearing potential must agree to use effective contraceptive measures (excluding unreliable methods such as rhythm method) from the time of signing the informed consent form until 1 year after the last dose of study drug, and must agree not to donate sperm or eggs;

⁃ The subject or their legally authorized representative has signed the informed consent form (ICF), indicating understanding of the study purpose and procedures and voluntary participation.