CD38-targeted antibody-drug conjugate 
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  • ||||||||||  Review, Journal:  Bispecific antibodies in multiple myeloma (Pubmed Central) -  Dec 31, 2021   
    BsAb have the capacity to bind two different antigens, one at the tumor cell surface and one on T cells (CD3), recreating the immune synapse. In this article, we discuss the main clinical data on BsAb in MM, as well as their different constructs and the potential mechanism of resistance.
  • ||||||||||  Darzalex IV (daratumumab) / J&J, Sarclisa (isatuximab-irfc) / Sanofi
    Journal, IO biomarker:  Isatuximab for the treatment of multiple myeloma. (Pubmed Central) -  Dec 6, 2021   
    While the administration of the drug remains intravenous, studies of fixed-volume infusion and rapid infusion may improve drug administration convenience. Ongoing studies are examining isatuximab in combination with other immune therapies and cellular therapies, conventional chemotherapy and across other disease entities.
  • ||||||||||  Darzalex IV (daratumumab) / J&J
    HOW I TREAT NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS? () -  Nov 27, 2021 - Abstract #EHOC2021EHOC_188;    
    Consolidation might be considered if the response previously achieved could be upgraded and maintenance will be able to maintain the response achieved and under the lenalidomide platform, new combinations are emerging like lenalidomide plus either daratumumab or carfilzomib.In the setting of transplant ineligible patients, the old standards of care bortezomib, melphalan and prednisone and continuous therapy with lenalidomide and dexamethasone have been replaced by daratumumab plus either VMP or Rd because the addition of daratumumab significantly improved the responses rate including complete responses and undetectable measurable disease but also the outcomes in terms of progression free and overall survival. Bortezomib, lenalidomide and dexamethasone is another combination maybe of choice for fit patients and the platform to which monoclonal antibodies anti CD38 are going to be added.
  • ||||||||||  Darzalex IV (daratumumab) / J&J
    Targeted Therapy in CD38 + Acute Myeloid Leukemia () -  Nov 24, 2021 - Abstract #ASH2021ASH_6165;    
    The patient, who was non-remission after Dara combined with IA chemotherapy (Idarubicin, Cytosine Arabinoside), achieved remission after CART targeting CD38. In this paper, four cases were reported, and the rationality of CD38 targeted therapy was further analyzed.
  • ||||||||||  Darzalex IV (daratumumab) / J&J
    Journal, IO biomarker:  Potent activity of an anti-ICAM1 antibody-drug conjugate against multiple myelom. (Pubmed Central) -  Nov 24, 2021   
    Patients receiving belamaf have triple-class refractory myeloma with multiple LOTs generally aligned with the current indication. We propose that anti-ICAM1 antibody-drug conjugate should be further studied for toxicity, and if safe, tested for clinical efficacy in patients with relapsed or refractory multiple myeloma.
  • ||||||||||  Darzalex IV (daratumumab) / J&J
    TREATMENT OF RELAPSED/REFRACTORY MULTIPLE MYELOMA () -  Nov 16, 2021 - Abstract #SIE2021SIE_19;    
    Selinexor, a selective inhibitor of nuclear export compound that blocks exportin 1 and forces nuclear accumulation and activation of tumour suppressor proteins, has been evaluated in combination with dexamethasone in patients previously exposed to (individually or in combination) bortezomib, carfilzomib, lenalidomide, pomalidomide, daratumumab, or an alkylating agent and had disease refractory to at least one proteasome inhibitor, one immunomodulatory agent, and daratumumab (triple-class refractory) in the phase 2 STORM study, showing an overall response rate of 30% and PFS of 3.7 months...Melflufen (melphalan flufenamide) is a first-in-class anti-cancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumour cells...These agents include antibody–drug conjugates, autologous chimeric antigen receptor engineered T cells (CAR T cells), and bispecific T cell or NK engagers. Little data are yet available for bispecific agents, and early clinical trials are ongoing.
  • ||||||||||  Review, Journal:  Impact of new myeloma agents on the transfusion laboratory. (Pubmed Central) -  Nov 12, 2021   
    RBC transfusion support for multiple myeloma patients receiving anti-CD38 or anti-CD47 drugs can be optimised by establishing good communication between the clinical teams and TSLs, building electronic notification processes, and ensuring timely completion of baseline pre-transfusion testing and RBC phenotype/genotype prior to starting therapy. Staff education, standardisation of laboratory mitigation measures, and implementation of testing algorithms that consider mAb-induced interference when working up a pan-agglutinin help to significantly decrease delays that would otherwise result if standard methods were employed to complete antibody identification studies.
  • ||||||||||  Darzalex IV (daratumumab) / J&J
    Journal:  Use of an in-house trypsin-based method to resolve the interference of daratumumab. (Pubmed Central) -  Nov 6, 2021   
    Our in-house trypsin-based method enables pretransfusion testing of patients receiving DARA in an accurate and cost-effective manner without missing clinically significant alloantibodies. This presents an additional testing option where DTT use is undesirable.
  • ||||||||||  Darzalex IV (daratumumab) / J&J
    Journal, IO biomarker:  Daratumumab for the treatment of multiple myeloma. (Pubmed Central) -  Nov 6, 2021   
    In this review, we examine the preclinical development of daratumumab, its pharmacology and clinical investigations that demonstrated its safety and efficacy. Furthermore, we discuss the outstanding questions related to daratumumab and ongoing clinical trials seeking to answer them.
  • ||||||||||  Darzalex IV (daratumumab) / J&J
    Efficacy and Safety of Daratumumab Monotherapy in Newly Diagnosed Patients with Stage 3B Light Chain Amyloidosis: A Phase 2 Study By the European Myeloma Network (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_4372;    
    Daratumumab, an IgGκ monoclonal antibody targeting CD38, has proved highly effective either alone or in combination with bortezomib, cyclophosphamide and dexamethasone and with good tolerability in AL amyloidosis patients. In this prospective phase 2 study, in patients with high-risk AL amyloidosis (stage 3B), daratumumab monotherapy shows a favorable safety profile and induced very rapid and deep hematologic responses with a median time to first response of 7 days, with 53% of the patients achieving VGPR or better and a 6-month OS of 70%.
  • ||||||||||  Darzalex IV (daratumumab) / J&J
    Blocking the Don’t Eat Me Signal (CD47-SIRPα Axis) to Improve Antibody-Based Immunotherapy of Multiple Myeloma (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_4324;    
    The addition of monoclonal antibodies daratumumab, elotuzumab and isatuximab to the treatment of patients with multiple myeloma significantly improved the outcome and prolonged survival...In patients with Non-Hodgkin’s lymphoma the combination of CD20 antibody rituximab with CD47 antibody magrolimab was clinically successful (Advani et al., NEJM 379:1711, 2018)...Initial data indicate that pre-treatment of myeloma cells with proteasome inhibitor carfilzomib did not negatively impact improvement of ADCP by blocking the CD47-SIRPα axis in responsive cell lines. Taken together, particularly CD38-targeting antibodies may have a significant potential to further improve immunotherapy in multiple myeloma patients.
  • ||||||||||  Darzalex IV (daratumumab) / J&J, CD38xICAM1 bispecific antibody / Virtuoso Therap
    CD38 x ICAM1 Bispecific Antibody Is a Novel Approach for Treating Multiple Myeloma and Lymphoma (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_4041;    
    Most importantly, the CD38 x ICAM1 bispecific antibody showed complete tumor inhibition in a rituximab-resistant lymphoma PDX model, whereas daratumumab only showed minimal efficacy. In conclusion, the CD38 x ICAM1 bispecific antibody demonstrated improved efficacy and specificity toward CD38 + and ICAM1 + tumor cells and represents a novel approach for treating multiple myeloma and lymphoma.
  • ||||||||||  Darzalex Faspro (daratumumab/hyaluronidase) / J&J
    Daratumumab As a Treatment for Adult Immune Thrombocytopenia: A Phase II Study with Safety Run-in (the DART Study) (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_3694;    
    P2
    Antiplatelet-specific plasma cells have been detected in the spleen of the rituximab refractory ITP patients...The safety run-in phase includes 3 patients who receive 4 weekly subcutaneous daratumumab injections followed by a 4-week observational period...Standard premedication before all daratumumab injections consists of antihistamine, corticosteroid (methylprednisolone 100 mg or equivalent before the 1 st daratumumab injection and 60 mg or equivalent before subsequent injections), and paracetamol...Steroid or TPO-RA (eltrombopag or romiplostim) dosing must remain stable during the 2 weeks preceding the inclusion...No serious or grade 3 adverse events were reported. Cohort 1 will start in August 2021.
  • ||||||||||  MM dual-CAR iNK / Fate Therap
    Dual Chimeric Antigen Receptor Approach Combining Novel Tumor Targeting Strategies Circumvents Antigen Escape in Multiple Myeloma (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_3301;    
    Since MM dual-CAR iNK cells also express CD16, which mediates antibody-dependent cellular cytotoxicity, combination with therapeutic antibodies, such as anti-CD38 antibodies, can be deployed to target three TAAs for a complete therapeutic approach in MM. The data highlights the applicability of a multi-targeted approach in MM patients, whereby MM dual-CAR NK and/or T cells maintain responsiveness to malignant cells that shed or downregulate tumor antigens to evade treatment.
  • ||||||||||  CFT7455 / C4 Therap
    A Phase 1 Study of CFT7455, a Novel Degrader of IKZF1/3, in Multiple Myeloma and Non-Hodgkin Lymphoma (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_3256;    
    P1/2
    Expansion cohorts of single-agent CFT7455 and CFT7455 plus dexamethasone in R/R MM, and single-agent CFT7455 for peripheral T-cell lymphoma and MCL are planned...Patients must not be candidates for regimens known to provide clinical benefit, defined as having received ≥3 prior anti-myeloma regimens including ≥2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid, and an anti-CD38 antibody...Approximately 164 patients at approximately 13 US sites will be enrolled. This trial is registered with clinicaltrials.gov as NCT04756726 , enrollment is ongoing.
  • ||||||||||  elranatamab (PF-06863135) / Pfizer
    Magnetismm-3: An Open-Label, Multicenter, Non-Randomized Phase 2 Study of Elranatamab (PF-06863135) in Patients with Relapsed or Refractory Multiple Myeloma (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_3255;    
    P1, P2
    Key exclusion criteria are smoldering MM, active plasma cell leukemia, amyloidosis, POEMS syndrome, active, uncontrolled bacterial, fungal or viral infections, stem cell transplant within 12 weeks of enrollment, any other active malignancy within 3 years prior to enrollment (except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ), or having received previous administration of an investigational drug within 30 days or 5 half-lives (whichever is longer) of the first dose of elranatamab. This study is, or is planned to be, open at centers in the USA, Australia, Canada, Belgium, France, Germany, Japan, Poland, Spain, and the UK.
  • ||||||||||  melphalan / Generic mfg., carmustine / Generic mfg.
    Clinical Outcomes of Relapsed/Refractory Multiple Myeloma Patients Following Treatment with Bispecific Antibodies (BiAbs) (GWCC - Hall A1) -  Nov 5, 2021 - Abstract #ASH2021ASH_2329;    
    Our data suggests that heavily pretreated, predominantly triple-class refractory, patients relapsing after BiAbs may still have good outcomes when sequentially treating with other immunological/T cell-directed therapeutics such as BiAbs and CAR T cells. Studying the appropriate sequence of these treatments is of paramount importance as BiAbs are expected to become part of the standard of care for RRMM patients.