Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic
(PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma.
(PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma.
Multiple Myeloma
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
GBR 1342
Mohan, Sanjay
International
Vanderbilt University
04-05-2018
Treatment
VICCHEMP17111
NCT03309111
Eligibility
18 Years
BOTH
NO
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
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
