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
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
- Conditions
- Plasma Cell Myeloma Recurrent
- Interventions
- First Posted Date
- 2022-06-06
- Last Posted Date
- 2024-11-14
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 531
- Registration Number
- NCT05405166
- Locations
- 🇺🇸
Arizona Oncology Associates, PC - HAL- Site Number : 8400015, Prescott Valley, Arizona, United States
🇺🇸Rocky Mountain Cancer Centers, LLP- Site Number : 8400021, Aurora, Colorado, United States
🇺🇸Mayo Clinic- Site Number : 8400008, Jacksonville, Florida, United States
Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma
- Conditions
- LymphomaNon-Hodgkin LymphomaMultiple MyelomaRelapsed Hodgkin's Disease, Adult
- Interventions
- Other: Standard Procedures
- First Posted Date
- 2022-04-26
- Last Posted Date
- 2024-07-19
- Lead Sponsor
- Divaya Bhutani
- Target Recruit Count
- 39
- Registration Number
- NCT05346809
- Locations
- 🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸Columbia University, New York, New York, United States
Post-Autologous Transplant Maintenance with Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
- First Posted Date
- 2022-04-25
- Last Posted Date
- 2025-01-13
- Lead Sponsor
- University of Illinois at Chicago
- Target Recruit Count
- 50
- Registration Number
- NCT05344833
- Locations
- 🇺🇸
University of Illinois at Chicago, Chicago, Illinois, United States
A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor
- Conditions
- Neoplasms, Plasma CellParaproteinemiasMultiple MyelomaNeoplasms by Histologic TypeBlood Protein DisordersHematologic DiseasesRenal ImpairmentNeoplasms
- Interventions
- First Posted Date
- 2022-03-28
- Last Posted Date
- 2022-03-28
- Lead Sponsor
- Hellenic Society of Hematology
- Target Recruit Count
- 108
- Registration Number
- NCT05298683
- Locations
- 🇬🇷
General Hospital of Athens "Evangelismos", Athens, Greece
🇬🇷Anticancer Oncology Hospital of Athens "Agios Savvas", Athens, Greece
🇬🇷General Hospital of Athens "Alexandra", Athens, Greece
A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients (SuppCare 001)
- Conditions
- Platelet RefractorinessHematologic Malignancy
- Interventions
- First Posted Date
- 2022-03-17
- Last Posted Date
- 2024-07-31
- Lead Sponsor
- Firas El Chaer, MD
- Target Recruit Count
- 3
- Registration Number
- NCT05284032
- Locations
- 🇺🇸
University of Virginia, Charlottesville, Virginia, United States
Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE MM Patients
- Conditions
- Multiple Myeloma
- First Posted Date
- 2022-03-09
- Last Posted Date
- 2025-03-25
- Lead Sponsor
- Canadian Myeloma Research Group
- Target Recruit Count
- 75
- Registration Number
- NCT05272826
- Locations
- 🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada
🇨🇦London Health Sciences Centre, London, Ontario, Canada
A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment
- Conditions
- Neoplasms, Plasma CellHematologic DiseasesMultiple MyelomaRenal ImpairmentBlood Protein DisordersParaproteinemiasNeoplasms by Histologic TypeNeoplasms
- Interventions
- First Posted Date
- 2021-12-07
- Last Posted Date
- 2022-03-29
- Lead Sponsor
- Hellenic Society of Hematology
- Target Recruit Count
- 51
- Registration Number
- NCT05147493
- Locations
- 🇬🇷
Anticancer Oncology Hospital of Athens "Agios Savvas", Athens, Greece
🇬🇷University General Hospital of Ioannina, Ioannina, Greece
🇬🇷Anticancer Hospital of Thessaloniki "Theageneio", Thessaloniki, Greece
Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple MyelomaCancer
- Interventions
- First Posted Date
- 2021-12-06
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Target Recruit Count
- 50
- Registration Number
- NCT05145400
- Locations
- 🇺🇸
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
🇺🇸Levine Cancer Institute, Charlotte, North Carolina, United States
🇺🇸Duke Comprehensive Cancer Center, Durham, North Carolina, United States
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2021-11-30
- Last Posted Date
- 2025-03-07
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 317
- Registration Number
- NCT05137054
- Locations
- 🇪🇸
Hospital Clínico Universitario de Santiago, Santiago, A Coruña, Spain
🇺🇸Scripps Clinic Torrey Pines, La Jolla, California, United States
🇺🇸Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Isa-RVD Study in Patients With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2021-11-17
- Last Posted Date
- 2025-04-10
- Lead Sponsor
- Cancer Trials Ireland
- Target Recruit Count
- 54
- Registration Number
- NCT05123131
- Locations
- 🇩🇰
Aarhus University Hospital, Aarhus, Denmark
🇮🇪Beaumont Hospital, Dublin, Ireland
🇮🇪Mater Misericordiae University Hospital, Dublin, Ireland
Drug Development Updates
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