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, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
- Conditions
- Immune System Disorder
- Interventions
- First Posted Date
- 2020-03-04
- Last Posted Date
- 2023-06-27
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 23
- Registration Number
- NCT04294459
- Locations
- 🇺🇸
Investigational Site Number :8400004, Houston, Texas, United States
🇺🇸Investigational Site Number :8400002, New York, New York, United States
🇺🇸Investigational Site Number :8400001, Rochester, Minnesota, United States
Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma in RelapseMultiple Myeloma, Refractory
- Interventions
- First Posted Date
- 2020-02-27
- Last Posted Date
- 2023-01-10
- Lead Sponsor
- Poitiers University Hospital
- Target Recruit Count
- 82
- Registration Number
- NCT04287855
- Locations
- 🇫🇷
CHU Poitiers, Poitiers, France
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
- Conditions
- Plasma Cell Myeloma
- Interventions
- First Posted Date
- 2020-02-17
- Last Posted Date
- 2024-10-31
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 337
- Registration Number
- NCT04270409
- Locations
- 🇦🇺
Investigational Site Number :0360008, Liverpool, New South Wales, Australia
🇯🇵Investigational Site Number :3920001, Shibuya-ku, Tokyo, Japan
🇱🇹Investigational Site Number :4400001, Vilnius, Lithuania
Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients with Renal Insufficiency
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2020-01-27
- Last Posted Date
- 2025-01-24
- Lead Sponsor
- Medical College of Wisconsin
- Target Recruit Count
- 41
- Registration Number
- NCT04240054
- Locations
- 🇺🇸
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2019-10-15
- Last Posted Date
- 2025-01-03
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 209
- Registration Number
- NCT04126200
- Locations
- 🇸🇪
GSK Investigational Site, Stockholm, Sweden
Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
- Conditions
- Multiple Myeloma
- Interventions
- Device: Investigational injector device
- First Posted Date
- 2019-08-06
- Last Posted Date
- 2024-04-29
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 56
- Registration Number
- NCT04045795
- Locations
- 🇦🇺
Investigational Site Number : 0360004, Fitzroy, Victoria, Australia
🇺🇸~Banner MD Anderson Cancer Center Site Number : 8400005, Gilbert, Arizona, United States
🇯🇵Investigational Site Number : 3920002, Okayama-shi, Okayama, Japan
A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2019-06-18
- Last Posted Date
- 2024-11-28
- Lead Sponsor
- Celgene
- Target Recruit Count
- 424
- Registration Number
- NCT03989414
- Locations
- 🇺🇸
Local Institution - 110, Winston-Salem, North Carolina, United States
🇨🇿Local Institution - 802, Brno, Czechia
🇨🇿Local Institution - 801, Ostrava-Poruba, Czechia
Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
- Conditions
- Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia
- Interventions
- First Posted Date
- 2019-03-04
- Last Posted Date
- 2024-05-16
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 67
- Registration Number
- NCT03860844
- Locations
- 🇺🇸
Children's Medical Center of Dallas-Site Number:8400002, Dallas, Texas, United States
🇲🇽Investigational Site Number :4840001, Monterrey, Nuevo León, Mexico
🇧🇷Investigational Site Number :0760007, Porto Alegre, Rio Grande Do Sul, Brazil
A Study of Isatuximab-based Therapy in Participants With Lymphoma
- First Posted Date
- 2018-12-07
- Last Posted Date
- 2023-10-17
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 58
- Registration Number
- NCT03769181
- Locations
- 🇰🇷
Investigational Site Number :4100001, Gangnam-gu, Seoul-teukbyeolsi, Korea, Republic of
🇪🇸Investigational Site Number :7240003, Barcelona, Barcelona [Barcelona], Spain
🇫🇷Investigational Site Number :2500007, Pessac, France
Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma
- First Posted Date
- 2018-11-07
- Last Posted Date
- 2023-09-08
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 25
- Registration Number
- NCT03733717
- Locations
- 🇨🇳
Investigational Site Number 1560003, Beijing, China
🇨🇳Investigational Site Number 1560001, Tianjin, China
🇨🇳Investigational Site Number 1560002, Nanjing, China
Drug Development Updates
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