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
Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies
- First Posted Date
- 2018-08-20
- Last Posted Date
- 2023-07-10
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 107
- Registration Number
- NCT03637764
- Locations
- 🇺🇸
Investigational Site Number :8400007, Boston, Massachusetts, United States
🇺🇸Investigational Site Number :8400004, Santa Monica, California, United States
🇺🇸Investigational Site Number :8400002, Houston, Texas, United States
Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2018-08-06
- Last Posted Date
- 2025-01-24
- Lead Sponsor
- University of Heidelberg Medical Center
- Target Recruit Count
- 662
- Registration Number
- NCT03617731
- Locations
- 🇩🇪
Universitätsklinik der Justus-Liebig-Universität, Medizinische Klinik IV, Gießen, Germany
🇩🇪Katholisches Karl-Leisner-Klinikum gGmbH, Wilhelm-Anton-Hospital Goch, Klinik für Hämatologie - Onkologie, Goch, Germany
🇩🇪Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/Onkologie, Hagen, Germany
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)
- Conditions
- Colorectal Cancer
- Interventions
- First Posted Date
- 2018-06-13
- Last Posted Date
- 2023-11-07
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 96
- Registration Number
- NCT03555149
- Locations
- 🇫🇷
Centre Leon Berard, Lyon, France
🇰🇷Samsung Medical Center, Seoul, Korea, Republic of
🇺🇸Memorial Sloan-Kettering Cancer Center, New York, New York, United States
A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma
- Conditions
- LymphomaMultiple MyelomaAcute Myeloid LeukemiaDiffuse Large B-Cell Lymphoma
- Interventions
- Drug: Anti-CD20 Targeting agent
- First Posted Date
- 2018-05-21
- Last Posted Date
- 2023-12-22
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 177
- Registration Number
- NCT03530683
- Locations
- 🇺🇸
LAC+USC Medical Center, Los Angeles, California, United States
🇺🇸USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸Northside Hospital, Atlanta, Georgia, United States
S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis
- Conditions
- Gastrointestinal HemorrhageHepatomegalyNauseaConstipationPrimary Systemic AmyloidosisRecurrent Primary AmyloidosisAmorphous, Eosinophilic, and Acellular DepositDiarrheaPurpuraRefractory Primary Amyloidosis
- Interventions
- Other: Laboratory Biomarker Analysis
- First Posted Date
- 2018-04-17
- Last Posted Date
- 2025-02-27
- Lead Sponsor
- SWOG Cancer Research Network
- Target Recruit Count
- 43
- Registration Number
- NCT03499808
- Locations
- 🇺🇸
Saint Mary Corwin Medical Center, Pueblo, Colorado, United States
🇺🇸The Carle Foundation Hospital, Urbana, Illinois, United States
🇺🇸Genesee Hematology Oncology PC, Flint, Michigan, United States
Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies
- Conditions
- Prostate CancerNon-small Cell Lung Cancer
- Interventions
- First Posted Date
- 2017-12-11
- Last Posted Date
- 2022-05-16
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 44
- Registration Number
- NCT03367819
- Locations
- 🇨🇳
Investigational Site Number 1580002, Tainan, Taiwan
🇬🇧Investigational Site Number 8260001, Sutton, Surrey, United Kingdom
🇺🇸Investigational Site Number 8400007, Atlanta, Georgia, United States
A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
- Conditions
- Plasma Cell Myeloma
- Interventions
- First Posted Date
- 2017-10-24
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 475
- Registration Number
- NCT03319667
- Locations
- 🇺🇸
Investigational Site Number: 8400006, Fort Myers, Florida, United States
🇺🇸Investigational Site Number: 8400004, Saint Petersburg, Florida, United States
🇺🇸Investigational Site Number: 8400007, Kansas City, Missouri, United States
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
- Conditions
- Plasma Cell Myeloma
- Interventions
- First Posted Date
- 2017-09-07
- Last Posted Date
- 2025-02-04
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 302
- Registration Number
- NCT03275285
- Locations
- 🇺🇸
UCSF MS Center Site Number : 8400002, San Francisco, California, United States
🇺🇸Spartanburg Medical Center Site Number : 8400003, Spartanburg, South Carolina, United States
🇦🇺Investigational Site Number : 0360005, Blacktown, New South Wales, Australia
Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
- Conditions
- Plasma Cell Myeloma
- Interventions
- First Posted Date
- 2017-06-21
- Last Posted Date
- 2024-06-14
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 109
- Registration Number
- NCT03194867
- Locations
- 🇬🇷
Investigational Site Number :3000001, Athens, Greece
🇨🇦Investigational Site Number :1240003, Sherbrooke, Quebec, Canada
🇮🇹Investigational Site Number :3800003, Brescia, Italy
Evaluation iNduction, Consolidation and Maintenance Treatment With Isatuximab , Carfilzomib, LEnalidomide and Dexamethasone
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2017-04-07
- Last Posted Date
- 2024-05-29
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Target Recruit Count
- 246
- Registration Number
- NCT03104842
- Locations
- 🇩🇪
Vivantes Am Urban, Berlin, Germany
🇩🇪Städt. Kliniken Bielefeld Klinikum Mitte, Bielefeld, Germany
🇩🇪Campus Benjamin Franklin Charite Berlin, Berlin, Germany
Drug Development Updates
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