Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
NCT ID: NCT03309111
Last Updated: 2024-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
81 participants
INTERVENTIONAL
2017-10-25
2023-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ISB 1342
Part 1: Cohorts of multiple ISB 1342 dose levels; Part 2: One dose regimen until disease progression or other discontinuation criterion is met
ISB 1342
ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion or subcutaneous injection (SC)
Interventions
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ISB 1342
ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion or subcutaneous injection (SC)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Glenmark Pharmaceuticals S.A.
INDUSTRY
Ichnos Sciences SA
INDUSTRY
Responsible Party
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Locations
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Colorado Blood Cancer Institute
Denver, Colorado, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Beth Israel
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Duke Clinical Research Institute
Durham, North Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
CHU de Nantes - Hôtel-Dieu
Nantes, Cedex, France
CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
Pessac, Cedex, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Cedex, France
CHU de Poitiers
Poitiers, Cedex, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, Cedex, France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, Cedex, France
CHRU de Tours - Hôpital Bretonneau
Tours, Cedex, France
CHU Hôpital Henri Mondor
Créteil, , France
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Lille, , France
L'Institut Paoli - Calmettes
Marseille, , France
Hôpital Saint-Antoine
Paris, , France
Countries
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Other Identifiers
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2016-005253-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISB 1342-101
Identifier Type: -
Identifier Source: org_study_id
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