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

Completed · Phase 1

Conditions studied: Relapsed/Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT03309111

Run by

Ichnos Sciences SA

People needed

81

Starts

2017-10-25

Expected to finish

2023-12-15

Last updated by the study team

2024-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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