A Clinical Study of SHR-5421 in Patients With Multiple Myeloma

Inclusion criteria

• Age ≥ 18 years, male or female.
• Expected survival ≥ 3 months.
• ECOG performance status 0 or 1.
• Diagnosed with active multiple myeloma per IMWG criteria.
• Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy.
• Disease progression or non-response to the most recent therapy.
• Measurable disease as defined by serum/urine M-protein or serum free light chain.
• Adequate bone marrow, hepatic, renal, and coagulation function.
• Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception.
• Willing and able to provide written informed consent and comply with study procedures.

Exclusion criteria

• Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.
• Central nervous system involvement by tumor.
• History of ≥ Grade 3 CRS with prior T-cell redirecting therapy.
• Requirement for dialysis or plasmapheresis within 14 days prior to study drug.
• Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies).
• Concurrent participation in another clinical study.
• Prior anti-tumor therapy within specified washout periods.
• Major surgery within 28 days prior to informed consent or planned during the study.
• Live attenuated vaccine within 4 weeks prior to first dose or planned during the study.
• Significant comorbidity that in the investigator's judgment would interfere with study participation or safety.
• Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo).
• Active infection.
• Known hypersensitivity or contraindication to SHR-5421.