Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma

Inclusion Criteria

• Documented diagnosis of multiple myeloma with measurable disease (serum, urine, or free light chain) per International Myeloma Working Group (IMWG) criteria, including non-secretory or oligo-secretory multiple myeloma which has relapsed after or is refractory to prior therapies, including proteasome inhibitors (PIs), immunomodulators (IMiDs) and anti-CD38 targeted therapies (daratumumab, isatuximab).
• Eastern Cooperative Oncology Group (ECOG) performance-status score of 2 or less and 1 or less (for France).
• Adequate hematologic, renal, and hepatic functions
• Seronegative for hepatitis B antigen; positive hepatitis B tests can be further evaluated by confirmatory tests, and if viral load is negative, the subject can be enrolled.
• Seronegative for hepatitis C antibody; if positive, then further test for the presence of antigen by hepatitis C virus polymerase chain reaction (HCV PCR). If HCV antigen tests are negative, then the subject can be enrolled.
• Oxygen saturation level ≥92% on room air.
• Left ventricular ejection fraction (LVEF) ≥50% and no pericardial or pleural effusion at Screening

Exclusion Criteria

• Active central nervous system involvement
• Exposure to daratumumab or isatuximab within 2 months prior to the start of study treatment
• Active plasma cell leukemia
• Active infectious disease
• Clinically significant cardiovascular and respiratory conditions
• History of HIV infection
• Subjects requiring prohibited concomitant medications