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
Isatuximab and Iberdomide As Immunotherapy for High Risk in Smouldering Myeloma
- Conditions
- Smouldering Myeloma
- Interventions
- First Posted Date
- 2025-03-25
- Last Posted Date
- 2025-03-25
- Lead Sponsor
- University College, London
- Target Recruit Count
- 63
- Registration Number
- NCT06762769
ELISA in Relapsed/Refractory MM
- Conditions
- Relapsed Refractory Multiple Myeloma (RRMM)Relapsed Refractory Multiple Myeloma
- Interventions
- First Posted Date
- 2025-02-18
- Last Posted Date
- 2025-02-18
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 30
- Registration Number
- NCT06832865
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia
- First Posted Date
- 2024-10-18
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- Goethe University
- Target Recruit Count
- 40
- Registration Number
- NCT06648889
- Locations
- 🇩🇪
University Hospital Augsburg, II. Medizinischen Klinik, Hämatologie, internistische Onkologie und Hämostaseologie, Augsburg, Germany
🇩🇪University Hospital Erlangen AöR, Department of Medicine 5, Erlangen, Germany
🇩🇪Goethe University Hospital Frankfurt, Department of Medicine, Hematology and Oncology, Frankfurt am Main, Germany
Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma
- Conditions
- Multiple MyelomaPlasma Cell Leukemia
- Interventions
- First Posted Date
- 2024-07-24
- Last Posted Date
- 2025-04-17
- Lead Sponsor
- University of Utah
- Target Recruit Count
- 40
- Registration Number
- NCT06517017
- Locations
- 🇺🇸
Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, United States
A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
- Conditions
- Plasma Cell Myeloma Refractory
- Interventions
- First Posted Date
- 2024-04-10
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 64
- Registration Number
- NCT06356571
- Locations
- 🇺🇸
Smilow Cancer Center at Yale-New Haven- Site Number : 8400020, New Haven, Connecticut, United States
🇺🇸Millennium Oncology- Site Number : 8400011, Pembroke Pines, Florida, United States
🇺🇸BRCR Global- Site Number : 8400008, Plantation, Florida, United States
Iberdomide Vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2024-01-22
- Last Posted Date
- 2024-10-18
- Lead Sponsor
- University of Heidelberg Medical Center
- Target Recruit Count
- 411
- Registration Number
- NCT06216158
- Locations
- 🇩🇪
Helios Klinikum Bad Saarow, Bad Saarow, Germany
🇩🇪Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie, Berlin, Germany
🇩🇪Helios Klinikum Berlin-Buch, Berlin, Germany
Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma
- Conditions
- Refractory Multiple MyelomaRecurrent Multiple Myeloma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow Aspiration and BiopsyProcedure: EchocardiographyOther: Questionnaire AdministrationBiological: Universal Donor Expanded TGF-beta-imprinted NK Cells
- First Posted Date
- 2024-01-12
- Last Posted Date
- 2025-03-27
- Lead Sponsor
- Elvira Umyarova
- Target Recruit Count
- 30
- Registration Number
- NCT06203912
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
- Conditions
- Relapsed Multiple MyelomaMultiple MyelomaBlood CancerRelapsed Non-Hodgkin LymphomaRefractory Multiple MyelomaNHLRefractory Non-Hodgkin Lymphoma
- Interventions
- First Posted Date
- 2023-11-07
- Last Posted Date
- 2025-04-30
- Lead Sponsor
- Indapta Therapeutics, INC.
- Target Recruit Count
- 128
- Registration Number
- NCT06119685
- Locations
- 🇺🇸
Emory University Hospital, Atlanta, Georgia, United States
🇺🇸Valkyrie Clinical Trials, Los Angeles, California, United States
🇺🇸Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center, Lake Mary, Florida, United States
Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma
- Conditions
- Refractory Multiple MyelomaMultiple MyelomaRelapsed Cancer
- Interventions
- First Posted Date
- 2023-06-28
- Last Posted Date
- 2024-02-02
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 50
- Registration Number
- NCT05922501
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Isa-Pom-Dex in Elderly/Frail Subjects With RRMM
- Conditions
- Co-morbidityRelapseMultiple MyelomaRefractoryAging
- Interventions
- First Posted Date
- 2023-06-22
- Last Posted Date
- 2025-04-25
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Target Recruit Count
- 6
- Registration Number
- NCT05911321
- Locations
- 🇺🇸
Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
🇺🇸Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.