Status:
COMPLETED
Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
Lead Sponsor:
Ichnos Sciences SA
Collaborating Sponsors:
Glenmark Pharmaceuticals S.A.
Conditions:
Relapsed/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
This study is an open-label, multi-center, Phase 1 study of ISB 1342 in subjects with relapsed/refractory multiple myeloma refractory to proteasome inhibitors (PIs), immunomodulators (IMiDs), and dara...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03309111
Start Date
October 25 2017
End Date
December 15 2023
Last Update
June 13 2024
Active Locations (20)
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1
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
2
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
3
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, United States, 55905
4
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601