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, treatment-a-promising-new-option-for-relapsed-multiple-myeloma/" >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