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

Clinical Trials

Isatuximab As Upfront Therapy for the Treatment of High Risk AL Amyloidosis

Phase 1

Active, not recruiting

Conditions: AL Amyloidosis

Interventions: Drug: Bortezomib
Drug: Cyclophosphamide
Drug: Dexamethasone
Biological: Isatuximab

First Posted Date: 2021-02-15

Last Posted Date: 2025-02-03

Lead Sponsor: Emory University

Target Recruit Count: 11

Registration Number: NCT04754945

Locations: 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States

and more 3 locations

Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years).

Phase 3

Active, not recruiting

Conditions: Myeloma
Multiple Myeloma

Interventions: Drug: Isatuximab
Drug: Lenalidomide
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2021-02-12

Last Posted Date: 2022-09-07

Lead Sponsor: Poitiers University Hospital

Target Recruit Count: 270

Registration Number: NCT04751877

Locations: 🇫🇷
CHU Poitiers, Poitiers, France

Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)

Phase 2

Terminated

Conditions: Warm Autoimmune Hemolytic Anemia (wAIHA)

Interventions: Drug: Isatuximab SAR650984

First Posted Date: 2020-12-09

Last Posted Date: 2024-12-05

Lead Sponsor: Sanofi

Target Recruit Count: 8

Registration Number: NCT04661033

Locations: 🇮🇹
Investigational Site Number : 3800001, Milano, Italy
🇫🇷
Investigational Site Number : 2500001, Creteil Cedex, France
🇬🇧
Investigational Site Number : 8260001, London, London, City Of, United Kingdom

and more 3 locations

Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM

Phase 2

Recruiting

Conditions: Multiple Myeloma
Autologous Stem Cell Transplant
Newly Diagnosed Multiple Myeloma (NDMM)

Interventions: Drug: Isatuximab
Drug: Lenalidomide
Drug: Bortezomib Injection
Drug: Dexamethasone

First Posted Date: 2020-12-04

Last Posted Date: 2024-11-12

Lead Sponsor: Jacob Laubach, MD

Target Recruit Count: 52

Registration Number: NCT04653246

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Phase 1

Recruiting

Conditions: Plasma Cell Myeloma Refractory

Interventions: Drug: Isatuximab
Drug: Dexamethasone
Drug: Pegenzileukin
Drug: Pomalidomide
Drug: SAR439459
Drug: Belantamab mafodotin
Drug: Belumosudil
Drug: Evorpacept

First Posted Date: 2020-11-24

Last Posted Date: 2025-05-22

Lead Sponsor: Sanofi

Target Recruit Count: 197

Registration Number: NCT04643002

Locations: 🇬🇷
Investigational Site Number : 3000001, Athens, Greece
🇺🇸
University of Michigan Health System - Ann Arbor- Site Number : 8400004, Ann Arbor, Michigan, United States
🇺🇸
Roswell Park Cancer Institute- Site Number : 8400008, Buffalo, New York, United States

and more 22 locations

Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

Phase 2

Recruiting

Conditions: Monoclonal Gammopathy

Interventions: Drug: Isatuximab

First Posted Date: 2020-11-04

Last Posted Date: 2024-03-06

Lead Sponsor: Columbia University

Target Recruit Count: 27

Registration Number: NCT04614558

Locations: 🇺🇸
Massachusetts General Hospital, Renal Associates Clinic, Boston, Massachusetts, United States
🇺🇸
Columbia University Irving Medical Center, New York, New York, United States

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma

Phase 2

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Isatuximab
Drug: CellProtect

First Posted Date: 2020-09-22

Last Posted Date: 2023-10-11

Lead Sponsor: Karolinska Institutet

Target Recruit Count: 62

Registration Number: NCT04558931

Locations: 🇸🇪
Karolinska University Hospital, Huddinge, Stockholm, Sweden

Isa-KRd vs KRd in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation (IsKia TRIAL)

Phase 3

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Carfilzomib Lenalidomide Dexamethasone
Drug: Isatuximab Carfilzomib Lenalidomide Dexamethasone

First Posted Date: 2020-07-23

Last Posted Date: 2025-02-26

Lead Sponsor: European Myeloma Network B.V.

Target Recruit Count: 302

Registration Number: NCT04483739

Locations: 🇳🇱
Noordwest Ziekenhuisgroep Stichting - Internal Medicine - Hematology, Alkmaar, Netherlands
🇳🇱
Amsterdam-Vrije Universiteit Medical Center (VUMC), Amsterdam, Netherlands
🇳🇱
Amphia Hospital-Internal Medicine - Hematology, Breda, Netherlands

and more 38 locations

A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Active, not recruiting

Conditions: Plasma Cell Myeloma

Interventions: Drug: isatuximab SAR650984
Drug: Pomalidomide
Drug: Dexamethasone
Drug: Carfilzomib

First Posted Date: 2020-07-07

Last Posted Date: 2025-03-24

Lead Sponsor: Sanofi

Target Recruit Count: 586

Registration Number: NCT04458831

Locations: 🇩🇪
Investigational Site Number : 2760003, Berlin, Germany
🇩🇪
Investigational Site Number : 2760041, Berlin, Germany
🇫🇷
Investigational Site Number : 2500011, Vannes Cedex, France

and more 126 locations

KRDI in Transplant-Eligible MM

Phase 2

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Isatuximab
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2020-06-12

Last Posted Date: 2024-12-06

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 50

Registration Number: NCT04430894

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

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