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 and Efficacy of Isatuximab in Lymphoblastic Leukemia
- Conditions
- T-lymphoblastic Lymphoma/LeukaemiaT-cell Type Acute Leukemia-Precursor
- Interventions
- First Posted Date
- 2016-12-21
- Last Posted Date
- 2022-03-21
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 14
- Registration Number
- NCT02999633
- Locations
- 🇺🇸
Investigational Site Number 8400001, Houston, Texas, United States
🇺🇸Investigational Site Number 8400002, Atlanta, Georgia, United States
🇫🇮Investigational Site Number 2460001, Helsinki, Finland
Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
- Conditions
- Plasma Cell Myeloma
- Interventions
- First Posted Date
- 2016-12-13
- Last Posted Date
- 2025-01-17
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 307
- Registration Number
- NCT02990338
- Locations
- 🇺🇸
BRCR Medical Center Inc. Site Number : 8400002, Plantation, Florida, United States
🇺🇸Dana Farber Site Number : 8400006, Boston, Massachusetts, United States
🇦🇺Investigational Site Number : 0360004, St Leonards, New South Wales, Australia
Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR)
- Conditions
- Smoldering Plasma Cell Myeloma
- Interventions
- Other: Laboratory Biomarker Analysis
- First Posted Date
- 2016-11-09
- Last Posted Date
- 2025-05-01
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 61
- Registration Number
- NCT02960555
- Locations
- 🇺🇸
Mount Sinai Hospital, New York, New York, United States
🇺🇸M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients
- First Posted Date
- 2016-06-24
- Last Posted Date
- 2024-04-01
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 36
- Registration Number
- NCT02812706
- Locations
- 🇯🇵
Investigational Site Number :392012, Chuo-ku, Tokyo, Japan
🇯🇵Investigational Site Number :392003, Okayama-shi, Okayama, Japan
🇯🇵Investigational Site Number :392009, Osaka-shi, Osaka, Japan
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma
- First Posted Date
- 2015-08-04
- Last Posted Date
- 2022-04-25
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 55
- Registration Number
- NCT02514668
- Locations
- 🇺🇸
Investigational Site Number 840013, Canton, Ohio, United States
🇺🇸Investigational Site Number 840003, Scottsdale, Arizona, United States
🇫🇷Investigational Site Number 250008, Creteil Cedex, France
Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation
- Conditions
- Plasma Cell Myeloma
- Interventions
- First Posted Date
- 2015-07-31
- Last Posted Date
- 2024-01-29
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 90
- Registration Number
- NCT02513186
- Locations
- 🇫🇷
Investigational Site Number : 250003, Pierre Benite, France
🇫🇷Investigational Site Number : 250002, Nantes Cedex 01, France
🇫🇷Investigational Site Number : 250001, TOULOUSE Cedex 9, France
Phase Ib Study of SAR650984 in Combination With Carfilzomib for Treatment of Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2015-01-07
- Last Posted Date
- 2025-05-01
- Lead Sponsor
- Thomas Martin, MD
- Target Recruit Count
- 83
- Registration Number
- NCT02332850
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸Colorado Blood Cancer Institute, Denver, Colorado, United States
SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients
- Conditions
- Plasma Cell Myeloma
- Interventions
- First Posted Date
- 2014-11-05
- Last Posted Date
- 2021-07-09
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 54
- Registration Number
- NCT02283775
- Locations
- 🇺🇸
Investigational Site Number 840011, Decatur, Illinois, United States
🇺🇸Investigational Site Number 840015, Salt Lake City, Utah, United States
🇺🇸Investigational Site Number 840005, Seattle, Washington, United States
SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients
- Conditions
- Plasma Cell Myeloma
- Interventions
- First Posted Date
- 2012-12-17
- Last Posted Date
- 2023-07-13
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 57
- Registration Number
- NCT01749969
- Locations
- 🇺🇸
Investigational Site Number 840004, San Francisco, California, United States
🇺🇸Investigational Site Number 840003, Columbus, Ohio, United States
🇺🇸Investigational Site Number 840001, Tampa, Florida, United States
Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
- Conditions
- Hematological Malignancy
- Interventions
- First Posted Date
- 2010-03-10
- Last Posted Date
- 2024-11-01
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 351
- Registration Number
- NCT01084252
- Locations
- 🇪🇸
Investigational Site Number : 724008, Sevilla, Spain
🇹🇷Investigational Site Number : 792002, Ankara, Turkey
🇹🇷Investigational Site Number : 792005, Ankara, Turkey
Drug Development Updates
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