Isatuximab
- Generic Name
- Isatuximab
- Brand Names
- Sarclisa
- Drug Type
- Biotech
- CAS Number
- 1461640-62-9
- Unique Ingredient Identifier
- R30772KCU0
- Background
Isatuximab (formerly SAR650984) is a humanized, IgG1-derived monoclonal antibody (mAb) produced from a Chinese hamster ovary (CHO) cell line. Structurally, isatuximab is comprised of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains. It is a cytolytic antibody targeted against CD38, a glycoprotein found on the surface of some immune cells that is highly expressed by malignant plasma cells in multiple myeloma. Along with daratumumab, another anti-CD38 mAb, isatuximab constitutes a novel treatment modality for patients with difficult-to-treat multiple myeloma.
Following three consecutive years on the yearly "Antibodies to watch" list published in "mAb", a peer-reviewed scientific journal dedicated to antibody research, isatuximab was granted Orphan Drug designation and approved on March 2nd, 2020, for the treatment of multiple myeloma. It is manufactured by Sanofi-Aventis U.S. under the brand name Sarclisa.
- Indication
Isatuximab is indicated in combination with pomalidomide and dexamethasone for the treatment of multiple myeloma in adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. It is also indicated in combination carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
- Associated Conditions
- Multiple Myeloma (MM), Refractory Multiple Myeloma, Relapsed Multiple Myeloma
Open-Label, Phase II Trial of Isatuximab for Patients With Refractory Immune Cytopenias After Allogeneic Hematopoietic Cell Transplantation
- Conditions
- Refractory Immune CytopeniasBlood Cancer
- Interventions
- First Posted Date
- 2023-05-24
- Last Posted Date
- 2025-04-11
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 25
- Registration Number
- NCT05873205
- Locations
- 🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ), Commack, New York, United States
Isatuximab in Lung Transplant Recipients
- Conditions
- Antibody-mediated RejectionAllosensitization
- Interventions
- Procedure: bone marrow biopsy
- First Posted Date
- 2023-05-17
- Last Posted Date
- 2025-04-11
- Lead Sponsor
- NYU Langone Health
- Target Recruit Count
- 6
- Registration Number
- NCT05862766
- Locations
- 🇺🇸
NYU Langone Health, New York, New York, United States
Lenalidomide, Bortezomib and Dexamethasone Induction Therapy with Either Intravenous or Subcutaneous Isatuximab in Patients with Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2023-04-07
- Last Posted Date
- 2025-03-07
- Lead Sponsor
- University of Heidelberg Medical Center
- Target Recruit Count
- 514
- Registration Number
- NCT05804032
- Locations
- 🇩🇪
University of Würzburg, Med. Klinik und Poliklinik II, Würzburg, Germany
🇩🇪Universitätsklinikum Magdeburg, Magdeburg, Germany
🇩🇪Universitätsklinikum Münster, 1. Medizinische Klinik A, Münster, Germany
Post-Transplant Maintenance Therapy with Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
- First Posted Date
- 2023-03-20
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 61
- Registration Number
- NCT05776979
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Interventions
- First Posted Date
- 2023-01-30
- Last Posted Date
- 2024-11-14
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 74
- Registration Number
- NCT05704049
- Locations
- 🇦🇺
Investigational Site Number : 0360002, Wollongong, New South Wales, Australia
🇧🇷Hospital Mae de Deus Site Number : 0760002, Porto Alegre, Rio Grande Do Sul, Brazil
🇦🇺Investigational Site Number : 0360001, Fitzroy, Victoria, Australia
Elimination of Minimal Residual Disease After Transplant
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2023-01-19
- Last Posted Date
- 2024-07-03
- Lead Sponsor
- Medical College of Wisconsin
- Target Recruit Count
- 31
- Registration Number
- NCT05690984
- Locations
- 🇺🇸
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
- Conditions
- Plasma Cell Myeloma
- Interventions
- First Posted Date
- 2023-01-03
- Last Posted Date
- 2025-01-23
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 70
- Registration Number
- NCT05669989
- Locations
- 🇺🇸
Washington University- Site Number : 8400001, Saint Louis, Missouri, United States
🇦🇺Investigational Site Number : 0360006, Blacktown, New South Wales, Australia
🇦🇺Investigational Site Number : 0360001, Saint Leonards, New South Wales, Australia
Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients
- Conditions
- Newly Diagnosed Multiple Myeloma
- Interventions
- Other: autologous stem cell transplant
- First Posted Date
- 2022-12-27
- Last Posted Date
- 2024-12-11
- Lead Sponsor
- University Hopsital Schleswig Holstein Campus Lübeck
- Target Recruit Count
- 100
- Registration Number
- NCT05665140
- Locations
- 🇩🇪
Heloisklinikum Berlin Buch GmbH, Berlin, Germany
🇩🇪Klinikum Bielefeld - Onkologie, Hämatologie, Paliativmedizin, Bielefeld, Germany
🇩🇪Universitätsklinikum Münster, Münster, Germany
Efficacy of the antiCD38 Monoclonal Antibody Isatuximab in the Treatment of PCRA by Major ABO Mismatch After Allogeneic Hematopoietic Stem Cell Transplantation
- First Posted Date
- 2022-09-29
- Last Posted Date
- 2022-09-29
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Target Recruit Count
- 90
- Registration Number
- NCT05559827
NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide
- Conditions
- Newly Diagnosed Multiple Myeloma
- Interventions
- First Posted Date
- 2022-09-28
- Last Posted Date
- 2022-09-28
- Lead Sponsor
- PETHEMA Foundation
- Target Recruit Count
- 480
- Registration Number
- NCT05558319
- Locations
- 🇪🇸
Hospital Principe de Asturias, Alcalá de Henares, Madrid, Spain
🇪🇸Hospital Germans Trias i Pujol (ICO BADALONA), Badalona, Spain
🇪🇸Clinica Universidad Navarra (CUN), Pamplona, Navarra, Spain
Drug Development Updates
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