A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma

Inclusion criteria

• Subjects in Parts 1(dose escalation) & 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study:

• Age ≥18 years. For Part 1, age ≥18 years and ≤75 years.
• Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria. Multiple myeloma is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma-defining events in protocol
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
• Life expectancy ≥3 months.
• Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.

Exclusion criteria

• Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
• Have amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or solitary plasmacytoma, or smoldering MM as defined by the International Myeloma Working Group(IMWG) criteria.
• Spinal cord compression that results in limited self-care occurs within 6 months prior to informed consent, or is expected to occur in the near future.
• History of primary immunodeficiency.
• Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.