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Sarclisa

(Isatuximab)

Phase 3Monoclonal antibody

AAzienda U.S.L. 1 di Massa e Carrara

Isatuximab is used to treat multiple myeloma, a type of blood cancer where abnormal plasma cells grow uncontrollably in the bone marrow. It works by helping the immune system recognize and destroy these cancer cells.[1] Sarclisa is currently being investigated across 22 indications[3], with its most advanced program in Phase 3.[1]

Sarclisa is one of 301 small molecule programs targeting Lymphoma. It is currently in Phase 3.

22

Indications

89

Total Trials

58

Active Trials

300

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

LymphomaActive, not recruiting

Multiple MyelomaActive, not recruiting

T-ALLRecruiting

Newly Diagnosed Multiple MyelomaRecruiting

DexamethasoneActive, not recruiting

Smouldering MyelomaRecruiting

Recurrent Plasma Cell MyelomaActive, not recruiting

Aplastic AnemiaRecruiting

Relapse Multiple MyelomaRecruiting

Newly DiagnosedActive, not recruiting

LymphomaPhase 2

Active, not recruiting

Multiple MyelomaPhase 3

Active, not recruiting

T-ALLPhase 2

Recruiting

Newly Diagnosed Multiple MyelomaPhase 3

Recruiting

DexamethasonePhase 2

Active, not recruiting

Smouldering MyelomaPhase 2

Recruiting

Recurrent Plasma Cell MyelomaPhase 2

Active, not recruiting

Aplastic AnemiaPreclinical

Recruiting

Relapse Multiple MyelomaPreclinical

Recruiting

Newly DiagnosedPhase 3

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Sarclisa

AAzienda U.S.L. 1 di Massa e Carrara

Zofran

Cabenuva

Norvir

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Kenalog

BBausch Health Americas, Inc.

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Decadron

QQuince Therapeutics S.p.A.

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

Bristol-Myers Squibb

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Allogeneic Hematopoietic Stem Cell Transplantation

NCT05559827

Phase 1/2Active, not recruiting

Multiple Myeloma

NCT03989414

Q1 2027

Phase 2Recruiting

Multiple Myeloma

NCT04835129

Phase 2Active, not recruiting

Monoclonal Gammopathy

NCT04614558

Phase 2Active, not recruiting

Multiple Myeloma

NCT04126200

PreclinicalActive, not recruiting

Multiple Myeloma

NCT07217184

Clinical

Trials by Indication[1]

Multiple Myeloma42 trials

Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma

Active, not recruiting·PPoitiers University Hospital·Phase 2·NCT04287855·82 enrolled

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

Completed· Sanofi logo

Sanofi·Phase 3·NCT03275285·302 enrolled

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

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT03319667·475 enrolled

Show 39 more trials

Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma

Terminated·WWashington University School of Medicine·Phase 1·NCT04083898·15 enrolled

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

Terminated· Pfizer logo

Pfizer·Phase 1·NCT03530683·189 enrolled

Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease

Terminated·WWashington University School of Medicine·Phase 1·NCT04912427·1 enrolled

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)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT03989414·424 enrolled

A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment

Unknown status·HHellenic Society of Hematology·Phase 2·NCT05147493·51 enrolled

Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Completed· Sanofi logo

Sanofi·Phase 1·NCT04045795·56 enrolled

Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma

Completed· Sanofi logo

Sanofi·Phase 1·NCT03733717·25 enrolled

Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Completed· Sanofi logo

Sanofi·Phase 1/2·NCT03194867·109 enrolled

Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients

Completed· Sanofi logo

Sanofi·Phase 1/2·NCT02812706·36 enrolled

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Recruiting· Sanofi logo

Sanofi·Phase 2·NCT06356571·64 enrolled

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT04270409·337 enrolled

Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Active, not recruiting· GSK logo

GSK·Phase 2·NCT04126200·208 enrolled

A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT05704049·118 enrolled

Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients

Recruiting·—·Phase 2/3·NCT05665140·100 enrolled

Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma

Completed·UUniversity of Heidelberg Medical Center·Phase 3·NCT05804032·514 enrolled

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients

Completed· Sanofi logo

Sanofi·Phase 3·NCT02990338·307 enrolled

Isa-RVD Study in Patients With Newly Diagnosed Multiple Myeloma

Active, not recruiting·CCancer Trials Ireland·Phase 2·NCT05123131·54 enrolled

Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma

Recruiting·MMassachusetts General Hospital·Phase 2·NCT05922501·50 enrolled

Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

Recruiting·MMedical College of Wisconsin·Phase 2·NCT04835129·53 enrolled

Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)

Recruiting·PPETHEMA Foundation·Phase 2·NCT07045909·30 enrolled

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

Completed· Sanofi logo

Sanofi·Phase 1·NCT02513186·90 enrolled

Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR)

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02960555·61 enrolled

Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma

Recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT05145400·50 enrolled

Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05776979·61 enrolled

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma

Completed· Sanofi logo

Sanofi·Phase 1·NCT02514668·55 enrolled

Phase Ib Study of SAR650984 in Combination With Carfilzomib for Treatment of Relapsed or Refractory Multiple Myeloma

Active, not recruiting·TThomas Martin, MD·Phase 1·NCT02332850·83 enrolled

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).

Active, not recruiting·PPoitiers University Hospital·Phase 3·NCT04751877·270 enrolled

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

Recruiting·KKarolinska Institutet·Phase 2·NCT04558931·62 enrolled

A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration Versus Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma

Recruiting·CCanadian Cancer Trials Group·Phase 3·NCT06182774·570 enrolled

Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma: A Phase 2 Multicenter Study

Recruiting·UUniversity of Utah·Phase 2·NCT06517017·40 enrolled

Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma (NDMM)

Not yet recruiting·DDana-Farber Cancer Institute·Phase 3·NCT07624513·720 enrolled

A Single Arm, Response-adapted, Open Label Study of Iberdomide, Weekly Bortezomib and Dexamethasone (IberBd) With Isatuximab Added on Demand for Transplant-ineligible, Newly Diagnosed Multiple Myeloma Patients: the BOREALIS Trial

Recruiting·CCanadian Myeloma Research Group·Phase 2·NCT05272826·75 enrolled

Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma

Recruiting·UUniversity of Illinois at Chicago·Phase 2·NCT05344833·50 enrolled

A Randomized Phase III Trial Assessing Iberdomide Versus Iberdomide Plus Isatuximab Maintenance Therapy Post Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

Active, not recruiting·UUniversity of Heidelberg Medical Center·Phase 3·NCT06216158·411 enrolled

Isa-VRdlite for of Frail and/or Much Older Patients With High Risk Newly Diagnosed Multiple Myeloma Base on Circulating Plasma Cells

Not yet recruiting·TThe Affiliated People's Hospital of Ningbo University·Preclinical·NCT07732712·15 enrolled

Combination Post-transplant Consolidation Therapy With Isatuximab, Lenalidomide, Dexamethasone (IsaRD) in Multiple Myeloma Patients With Persistent Marrow Minimal Residual Disease (Elimination of MRD After Transplant; E-MAT)

Active, not recruiting·MMedical College of Wisconsin·Phase 2·NCT05690984·30 enrolled

Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Phase 1·NCT05137054·317 enrolled

A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5- Sub-study 5 - Belantamab Mafodotin and Isatuximab in Combination

Active, not recruiting· GSK logo

GSK·Preclinical·NCT07217184·30 enrolled

A Single-Arm, Multicenter, Prospective, Observational Clinical Study on the Efficacy and Safety of Isatuximab Combined With Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) Regimen in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI-NDMM) Patients

Recruiting·SShanghai Zhongshan Hospital··NCT07663253·333 enrolled

Dexamethasone4 trials

SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients

Completed· Sanofi logo

Sanofi·Phase 1·NCT01749969·57 enrolled

SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients

Completed· Sanofi logo

Sanofi·Phase 1·NCT02283775·54 enrolled

Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM

Active, not recruiting·—·Phase 2·NCT04653246·52 enrolled

Show 1 more trial

A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor

Unknown status·HHellenic Society of Hematology·Phase 2·NCT05298683·108 enrolled

Newly Diagnosed Multiple Myeloma3 trials

A Phase 1b/2 Study of the Combination Isatuximab, Iberdomide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible or Not Intended for Upfront Transplant

Not yet recruiting·DDana-Farber Cancer Institute·Preclinical·NCT07601100·88 enrolled

Phase III Open-Label, Randomised Study of Consolidation With AZD0120 (Dual-Targeting BCMA/CD19 CAR-T) vs Continuous Standard Therapy in NDMM Patients Ineligible for ASCT as Initial Therapy (DURGA-5)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07764978·750 enrolled

GEM21menos65. A Phase III Trial for NDMM Patients Who Are Candidates for ASCT Comparing Extended VRD Plus Early Rescue Intervention vs Isatuximab-VRD vs Isatuximab-V-Iberdomide-D

Recruiting·PPETHEMA Foundation·Phase 3·NCT05558319·480 enrolled

Plasma Cell Myeloma3 trials

A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT05405166·531 enrolled

International, Multi-center, Open-label, Treatment Extension Study in Patients With Multiple Myeloma Who Are Still Benefitting From Isatuximab-based Therapy Following Completion of a Phase 1, 2, or 3 Parental Study

Enrolling by invitation· Sanofi logo

Sanofi·Phase 2·NCT05669989·70 enrolled

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

Completed· Sanofi logo

Sanofi··NCT04458831·583 enrolled

Lymphoma2 trials

A Study of Isatuximab-based Therapy in Participants With Lymphoma

Terminated· Sanofi logo

Sanofi·Phase 1/2·NCT03769181·58 enrolled

Randomized Phase 2 Trial of Isatuximab During Autologous Stem Cell Collection and Transplantation Period in Patients With Multiple Myeloma, Relapsed Hodgkin's and Non-Hodgkin's Lymphoma

Active, not recruiting·DDivaya Bhutani·Phase 2·NCT05346809·8 enrolled

31 more indications

Advanced Malignancies2 trials

Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies

Terminated· Sanofi logo

Sanofi·Phase 1/2·NCT03637764·107 enrolled

Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies

Terminated· Sanofi logo

Sanofi·Phase 1/2·NCT03367819·44 enrolled

AL amyloidosis2 trials

Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy

Recruiting·IIntergroupe Francophone du Myelome·Phase 2·NCT05066607·46 enrolled

Slow-Go Strategy for High Risk AL Amyloidosis: Isatuximab for Upfront Therapy

Active, not recruiting·EEmory University·Phase 1·NCT04754945·11 enrolled

Amyloidosis2 trials

S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

Completed·SSWOG Cancer Research Network·Phase 2·NCT03499808·43 enrolled

Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis

Withdrawn·TTufts Medical Center·Phase 2·NCT04943302

Recurrent Multiple Myeloma2 trials

Isa-CAPED MM: Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone (Isa-KPd) for Patients With Relapsed/Refractory Multiple Myeloma

Active, not recruiting·UUniversity of Washington·Phase 2·NCT04883242·30 enrolled

A Phase Ib Study of TGFbi NK Cells and Isatuximab for Myeloma Relapsed/Refractory to BCMA Targeting Therapy

Completed·EElvira Umyarova·Phase 1·NCT06203912·3 enrolled

Leukemia1 trial

Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Terminated· Sanofi logo

Sanofi·Phase 2·NCT02999633·14 enrolled

Minimal Residual Disease1 trial

MInimal Residual Disease Adapted Strategy

Active, not recruiting·IIntergroupe Francophone du Myelome·Phase 3·NCT04934475·791 enrolled

Newly Diagnosed1 trial

Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)

Active, not recruiting·UUniversity of Heidelberg Medical Center·Phase 3·NCT03617731·662 enrolled

Age1 trial

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Recruiting· Sanofi logo

Sanofi·Phase 1/2·NCT04643002·258 enrolled

Hematological Malignancies1 trial

Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies

Completed· Sanofi logo

Sanofi·Phase 1/2·NCT01084252·351 enrolled

Warm Autoimmune Hemolytic Anemia1 trial

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

Terminated· Sanofi logo

Sanofi·Phase 2·NCT04661033·8 enrolled

Smouldering Myeloma1 trial

Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma

Recruiting·UUniversity College, London·Phase 2·NCT06762769·63 enrolled

Acute Lymphoblastic Leukemia1 trial

Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Terminated· Sanofi logo

Sanofi·Phase 2·NCT03860844·67 enrolled

Cryoglobulinemia1 trial

Isatuximab in Type I Cryoglobulinemia

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05114109·21 enrolled

Kidney Transplant1 trial

Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation

Terminated· Sanofi logo

Sanofi·Phase 1/2·NCT04294459·23 enrolled

Hematologic Cancer1 trial

IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

Recruiting·IIndapta Therapeutics, INC.·Phase 1/2·NCT06119685·128 enrolled

Metastatic Colorectal Cancer1 trial

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

Terminated· Roche logo

Roche·Phase 1/2·NCT03555149·96 enrolled

Renal insufficiency1 trial

Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency

Recruiting·MMedical College of Wisconsin·Phase 2·NCT04240054·41 enrolled

Elderly1 trial

Isa-Pom-Dex in Elderly/Frail Subjects With RRMM

Active, not recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT05911321·6 enrolled

Lung Transplant Recipient1 trial

Isatuximab in Lung Transplant Recipients

Withdrawn·NNYU Langone Health·Phase 1·NCT05862766

Relapsed or Refractory1 trial

Study of Isatuximab and Cemiplimab in Relapsed or Refractory Natural Killer/T-cell Lymphoid Malignancy

Recruiting·WWon Seog Kim·Phase 2·NCT04763616·37 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Efficacy of the antiCD38 Monoclonal Antibody Isatuximab in the Treatment of PCRA by Major ABO Mismatch After Allogeneic Hematopoietic Stem Cell Transplantation

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05559827·90 enrolled

Maintenance Treatment1 trial

Evaluation iNduction, Consolidation and Maintenance Treatment With Isatuximab , Carfilzomib, LEnalidomide and Dexamethasone

Active, not recruiting·UUniversitätsklinikum Hamburg-Eppendorf·Phase 2·NCT03104842·246 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

Open-Label, Phase II Trial of Isatuximab for Patients With Refractory Immune Cytopenias After Allogeneic Hematopoietic Cell Transplantation

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05873205·12 enrolled

Plasma Cell Leukemia (PCL)1 trial

A Prospective, Single-Arm, Single-Center, Phase II Study Evaluating the Safety and Efficacy of CM336 in Combination With Isatuximab, Lenalidomide, and Bortezomib in Newly Diagnosed Primary Plasma Cell Leukemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07652905·24 enrolled

Relapsed Refractory Multiple Myeloma (RRMM)1 trial

A Phase 2 Study of Elranatamab in Combination With Isatuximab (ELISA) in Relapsed and Refractory Multiple Myeloma

Recruiting·MMassachusetts General Hospital·Phase 2·NCT06832865·30 enrolled

Relapse Multiple Myeloma1 trial

Phase Ib/II Study of Selinexor in Combination With Carfilzomib, Subcutaneous Isatuximab Administered Via Investigational Device and Dexamethasone (SCID) for Patients With Relapsed and/or Relapsed Refractory Multiple Myeloma

Recruiting·NNatalie Callander·Preclinical·NCT07479979·62 enrolled

T-ALL1 trial

A Multicenter, Single-arm Phase II Study to Assess the Safety, Tolerability, and Efficacy of Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia (GMALL-Isatuximab)

Recruiting·GGoethe University·Phase 2·NCT06648889·28 enrolled

Monoclonal Gammopathy1 trial

A Single Arm, Multicenter, Phase II, Open-Label Trial to Evaluate Efficacy of Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

Active, not recruiting·CColumbia University·Phase 2·NCT04614558·12 enrolled

Aplastic Anemia1 trial

A Phase I/II Study on the Safety and Efficacy of CD38 Monoclonal Antibody in the Treatment of Refractory Severe Aplastic Anemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT07714512·32 enrolled

Recurrent Plasma Cell Myeloma1 trial

A Single-Arm Phase II Study of Isatuximab With Carfilzomib and Pomalidomide in Relapsed or Refractory Multiple Myeloma

Active, not recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT04850599·5 enrolled

Unspecified1 trial

KRDI in Transplant-Eligible MM

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT04430894·50 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 2, 2020

SARCLISA

BLA BLA761113

Sources

References

[1]
ClinicalTrials.gov — 89 trial records for Isatuximab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Isatuximab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Isatuximab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761113). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Azienda U.S.L. 1 di Massa e Carrara company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Lymphocyte Differentiation Antigen CD38 Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: AAzienda U.S.L. 1 di Massa e Carrara

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