^
    28d
    Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Goethe University
    New P2 trial
    |
    bortezomib • Sarclisa (isatuximab-irfc)
    1m
    IONA-MM: A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov)
    P=N/A, N=586, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting | N=1200 --> 586
    Enrollment closed • Enrollment change
    |
    carfilzomib • dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc)
    1m
    Targeting CD38 with monoclonal antibodies disrupts key survival pathways in paediatric Burkitt's lymphoma malignant B cells. (PubMed, Clin Transl Immunology)
    This study investigates the effectiveness of CD38-targeting monoclonal antibodies (mAbs), daratumumab and isatuximab, in impairing crucial cellular processes and survival pathways in pBL malignant cells. The study also revealed a correlation between CD38 and MYC expression levels in pBL patient samples, suggesting CD38 involvement in key oncogenic processes. The study emphasises the therapeutic potential of CD38-targeting mAbs, particularly isatuximab, in pBL.
    Journal • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog)
    |
    MYC expression
    |
    Darzalex (daratumumab) • Sarclisa (isatuximab-irfc)
    2ms
    Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov)
    P1/2, N=258, Recruiting, Sanofi | N=197 --> 258
    Enrollment change • Combination therapy
    |
    dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • evorpacept (ALX148) • Blenrep (belantamab mafodotin-blmf) • SAR439459 • pegenzileukin (SAR444245)
    2ms
    Isatuximab for Delayed Red Cell Engraftment after Allogeneic Hematopoietic Cell Transplantation. (PubMed, Case Rep Hematol)
    She received therapy with rituximab, bortezomib, prednisone, and darbepoetin alfa with partial to no response. After repeated insurance denials for daratumumab, isatuximab was obtained from the manufacturer through their CareASSIST program. Following the completion of 2 cycles of isatuximab (8 doses), significant and sustained red cell recovery was observed.
    Journal
    |
    HLA-B (Major Histocompatibility Complex, Class I, B)
    |
    Rituxan (rituximab) • bortezomib • Darzalex (daratumumab) • prednisone • Sarclisa (isatuximab-irfc) • Aranesp (darbepoetin alfa)
    2ms
    TTI-622-01: 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 (clinicaltrials.gov)
    P1, N=189, Terminated, Pfizer | Active, not recruiting --> Terminated; A business decision was made by Pfizer to terminate the study. Termination was not due to any safety concerns, requests from regulatory authorities, changes to the benefit/risk profile or any new concerns regarding the investigational product.
    Trial termination • Combination therapy • Metastases
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 wild-type
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • azacitidine • carfilzomib • Sarclisa (isatuximab-irfc) • dexamethasone injection • maplirpacept (TTI-622)
    4ms
    Impact of Anti-CD38 Monoclonal Antibody Therapy on CD34+ Hematopoietic Stem Cell Mobilization, Collection, and Engraftment in Multiple Myeloma Patients-A Systematic Review. (PubMed, Pharmaceuticals (Basel))
    This systematic review examines the available clinical data on CD34+ cell mobilization, collection, and engraftment in multiple myeloma patients treated with the anti-CD38 monoclonal antibodies daratumumab and isatuximab in clinical trials and in real life...Most studies documented lower circulating CD34+ cells after mobilization compared to controls, leading to higher plerixafor requirements...Overall, anti-CD38 monoclonal antibodies appear to interfere with CD34+ cell mobilization, without consistently leading to significant clinical consequences. Further research is needed to elucidate the underlying mechanisms and define optimal mobilization strategies in this patient population.
    Review • Journal
    |
    CD34 (CD34 molecule)
    |
    Darzalex (daratumumab) • Sarclisa (isatuximab-irfc) • plerixafor
    4ms
    UltraFrailMM: Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, University of Utah
    New P2 trial
    |
    lenalidomide • dexamethasone • Sarclisa (isatuximab-irfc)
    4ms
    EMAT: Elimination of Minimal Residual Disease After Transplant (clinicaltrials.gov)
    P2; Trial completion date: Sep 2027 --> Jul 2026 | Trial primary completion date: Sep 2026 --> Jun 2026
    Trial completion date • Trial primary completion date • Minimal residual disease • Post-transplantation
    |
    clonoSEQ
    |
    lenalidomide • Sarclisa (isatuximab-irfc) • dexamethasone injection
    5ms
    Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, Emory University | Trial completion date: Sep 2026 --> Nov 2024 | Trial primary completion date: Sep 2025 --> Nov 2024
    Trial completion date • Trial primary completion date
    |
    bortezomib • cyclophosphamide • Sarclisa (isatuximab-irfc)
    5ms
    Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, Emory University | Recruiting --> Active, not recruiting | N=25 --> 11
    Enrollment closed • Enrollment change
    |
    bortezomib • cyclophosphamide • Sarclisa (isatuximab-irfc)
    5ms
    SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM (clinicaltrials.gov)
    P3, N=534, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting | Trial primary completion date: May 2024 --> Nov 2024
    Enrollment closed • Trial primary completion date • Combination therapy
    |
    dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • isatuximab subcutaneous (SAR650984 SC)
    5ms
    Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM (clinicaltrials.gov)
    P2, N=52, Recruiting, Jacob Laubach, MD | Active, not recruiting --> Recruiting | N=29 --> 52
    Enrollment open • Enrollment change
    |
    lenalidomide • bortezomib • Sarclisa (isatuximab-irfc) • dexamethasone injection
    6ms
    LINKER-MM2: A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments (clinicaltrials.gov)
    P1, N=317, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Aug 2032 --> Jan 2033
    Trial completion date • Combination therapy
    |
    lenalidomide • bortezomib • Libtayo (cemiplimab-rwlc) • carfilzomib • pomalidomide • Sarclisa (isatuximab-irfc) • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Ogsiveo (nirogacestat) • fianlimab (REGN3767) • linvoseltamab (REGN5458)
    6ms
    Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov)
    P1/2, N=197, Recruiting, Sanofi | Trial completion date: Dec 2027 --> Mar 2028 | Trial primary completion date: Dec 2027 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • evorpacept (ALX148) • Blenrep (belantamab mafodotin-blmf) • SAR439459 • pegenzileukin (SAR444245)
    6ms
    Human serum albumin-based drug-free macromolecular therapeutics induce apoptosis in chronic lymphocytic leukemia patient cells by crosslinking of CD20 and/or CD38 receptors. (PubMed, Drug Deliv Transl Res)
    Fab' fragments from Obinutuzumab (OBN) and Isatuximab (ISA) were employed in the synthesis of anti-CD20 (Fab'OBN-MORF1) and anti-CD38 (Fab'ISA-MORF1) bispecific engagers...Pretreatment of patient cells with gemcitabine or ricolinostat markedly increased cell surface CD20 and CD38 expression, respectively...Our findings demonstrate DFMT's potential in personalized CLL therapy. Further research is needed to validate these outcomes in a larger number of patient samples and to explore DFMT's applicability to other malignancies.
    Journal • IO biomarker
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    gemcitabine • Gazyva (obinutuzumab) • Sarclisa (isatuximab-irfc) • rocilinostat (ACY-1215)
    6ms
    Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma With Isatuximab (clinicaltrials.gov)
    P=N/A, N=50, Recruiting, Pack Health | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Aug 2023 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    Sarclisa (isatuximab-irfc)
    6ms
    CC-92480-MM-002: 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) (clinicaltrials.gov)
    P1/2, N=424, Active, not recruiting, Celgene | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    bortezomib • Darzalex (daratumumab) • carfilzomib • dexamethasone • Sarclisa (isatuximab-irfc) • Empliciti (elotuzumab) • mezigdomide (CC-92480)
    7ms
    Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR) (clinicaltrials.gov)
    P2, N=61, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2025 --> Apr 2030
    Trial completion date
    |
    lenalidomide • Sarclisa (isatuximab-irfc)
    7ms
    Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov)
    P1, N=56, Completed, Sanofi | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    pomalidomide • Sarclisa (isatuximab-irfc) • isatuximab subcutaneous (SAR650984 SC)
    7ms
    Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
    P3, N=411, Recruiting, University of Heidelberg Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    dexamethasone • Sarclisa (isatuximab-irfc) • iberdomide (CC-220)
    8ms
    Phase Ib Study of SAR650984 in Combination With Carfilzomib for Treatment of Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=83, Active, not recruiting, Thomas Martin, MD | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    carfilzomib • Sarclisa (isatuximab-irfc) • dexamethasone injection
    8ms
    Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=15, Terminated, Washington University School of Medicine | Trial completion date: Nov 2028 --> Mar 2024 | Active, not recruiting --> Terminated; Decision made to not move forward with Phase II portion of trial
    Trial completion date • Trial termination
    |
    bendamustine • Sarclisa (isatuximab-irfc)
    8ms
    ITHACA: A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma (clinicaltrials.gov)
    P3, N=337, Active, not recruiting, Sanofi | Trial primary completion date: Jun 2028 --> Nov 2030
    Trial primary completion date • Combination therapy
    |
    lenalidomide • dexamethasone • Sarclisa (isatuximab-irfc) • dexamethasone injection
    8ms
    IsAMYP: Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy (clinicaltrials.gov)
    P2, N=46, Recruiting, Intergroupe Francophone du Myelome | Trial completion date: May 2025 --> Mar 2026 | Trial primary completion date: May 2025 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc)
    9ms
    CD38-Specific Gallium-68 Labeled Peptide Radiotracer Enables Pharmacodynamic Monitoring in Multiple Myeloma with PET. (PubMed, Adv Sci (Weinh))
    In conclusion, [68 Ga]Ga-AJ206 exhibits the salient features required for clinical translation, providing CD38-specific high-contrast images in multiple models of MM. [68 Ga]Ga-AJ206-PET could be useful for quantifying total CD38 levels and pharmacodynamics during therapy to evaluate approved and new therapies in MM and other diseases with CD38 involvement.
    PK/PD data • Journal • IO biomarker
    |
    CD38 (CD38 Molecule)
    |
    CD38 expression
    |
    Darzalex (daratumumab) • Sarclisa (isatuximab-irfc)
    9ms
    Isatuximab in Lung Transplant Recipients (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, NYU Langone Health | Trial completion date: Jul 2026 --> Jan 2027 | Initiation date: Jan 2024 --> Jul 2024 | Trial primary completion date: Jul 2025 --> Jan 2026
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Sarclisa (isatuximab-irfc)
    9ms
    CD46 and CD59 inhibitors enhance complement-dependent cytotoxicity of anti-CD38 monoclonal antibodies daratumumab and isatuximab in multiple myeloma and other B-cell malignancy cells. (PubMed, Cancer Biol Ther)
    The escape in the second treatment cycle was prevented by the pretreatment of cells with Ad35K++. Overall, our data demonstrate that Ad35K++ and rILYd4 are efficient co-therapeutics of daratumumab and isatuximab, specifically in multi-cycle treatment regimens, and could be used to improve treatment of multiple myeloma.
    Journal
    |
    CD59 (CD59 Molecule) • CD46 (CD46 Molecule)
    |
    Darzalex (daratumumab) • Sarclisa (isatuximab-irfc)
    9ms
    ISABELA: Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Massachusetts General Hospital | Initiation date: Nov 2023 --> Jun 2024
    Trial initiation date
    |
    pomalidomide • Sarclisa (isatuximab-irfc) • Blenrep (belantamab mafodotin-blmf)
    9ms
    Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma (clinicaltrials.gov)
    P2, N=39, Recruiting, Divaya Bhutani | Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: May 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    Sarclisa (isatuximab-irfc)
    9ms
    IMPEDE: Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=53, Recruiting, Medical College of Wisconsin | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    pomalidomide • Sarclisa (isatuximab-irfc) • Empliciti (elotuzumab)
    9ms
    Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease (clinicaltrials.gov)
    P1, N=1, Terminated, Washington University School of Medicine | Trial completion date: Mar 2027 --> Jan 2024 | Active, not recruiting --> Terminated; Low accrual
    Trial completion date • Trial termination
    |
    bortezomib • dexamethasone • Sarclisa (isatuximab-irfc)
    9ms
    Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov)
    P1, N=56, Active, not recruiting, Sanofi | Phase classification: P1b --> P1
    Phase classification • Combination therapy
    |
    pomalidomide • Sarclisa (isatuximab-irfc) • isatuximab subcutaneous (SAR650984 SC)
    9ms
    Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, Washington University School of Medicine | Phase classification: P1/2 --> P1 | Trial completion date: Dec 2023 --> Nov 2028
    Phase classification • Trial completion date
    |
    bendamustine • Sarclisa (isatuximab-irfc)
    9ms
    ITHACA: A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma (clinicaltrials.gov)
    P3, N=337, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    lenalidomide • dexamethasone • Sarclisa (isatuximab-irfc) • dexamethasone injection
    9ms
    The efficacy of Isatuximab plus Pomalidomine and Dexamethasone in patients with amyloid light-chain (AL) amyloidosis who have not responded to previous therapy (ACTRN12621001530819)
    P2, N=16, Active, not recruiting, Intergroupe francophone du myelome | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    pomalidomide • Sarclisa (isatuximab-irfc)
    10ms
    CyBorDSAR: 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 (clinicaltrials.gov)
    P1, N=90, Completed, Sanofi | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    lenalidomide • bortezomib • cyclophosphamide • Sarclisa (isatuximab-irfc)
    10ms
    Isa-Pom-Dex in Elderly/Frail Subjects With RRMM (clinicaltrials.gov)
    P2, N=49, Recruiting, UNC Lineberger Comprehensive Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc)
    10ms
    A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=39, Not yet recruiting, Oncotherapeutics | Initiation date: Dec 2023 --> Mar 2024
    Trial initiation date • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • TNFA (Tumor Necrosis Factor-Alpha)
    |
    Chr t(11;14)
    |
    Venclexta (venetoclax) • carfilzomib • Sarclisa (isatuximab-irfc) • dexamethasone injection
    10ms
    Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
    P3, N=411, Not yet recruiting, University of Heidelberg Medical Center
    New P3 trial
    |
    dexamethasone • Sarclisa (isatuximab-irfc) • iberdomide (CC-220)
    10ms
    NCI-2023-09969: Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=30, Recruiting, Elvira Umyarova | Not yet recruiting --> Recruiting
    Enrollment open • Immune cell
    |
    cyclophosphamide • Sarclisa (isatuximab-irfc) • Hemady (dexamethasone tablets) • UD TGFbetai NK cells
    10ms
    Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Elvira Umyarova
    New P1 trial • Immune cell
    |
    cyclophosphamide • Sarclisa (isatuximab-irfc) • Hemady (dexamethasone tablets) • UD TGFbetai NK cells