talacotuzumab (JNJ-56022473) / J&J 
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 8 Diseases   1 Trial   1 Trial   65 News 
  • ||||||||||  talacotuzumab (JNJ-56022473) / J&J
    Engineered Single Amino Acid Substitutions Protect Hematopoietic Stem and Progenitor Cells from CD123 Targeted Immunotherapy (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_3949;    
    We used the known co-crystal structure of CD123 bound to the mAb CSL362 (talacotuzumab) for computer-aided protein engineering...Variant IL-3 receptor engineered HSPC’s and paired immunotherapies could enable novel and targeted therapeutic interventions post HSCT to either treat minimal residual disease or be used as a salvage therapy. Such approaches could expand the therapeutic window and broaden indications and applications for targeted immunotherapies for various malignant and benign conditions.
  • ||||||||||  Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
    Beyond gemtuzumab ozogamicin: A systematic review of antibody therapies for acute myeloid leukemia. () -  Apr 28, 2022 - Abstract #ASCO2022ASCO_4321;    
    Antibody-based therapies are showing great promise for the treatment of AML but are associated with various adverse effects. More prospective clinical trials are needed to further assess the long-term benefits of such medications.AE: adverse events; GI: gastrointestinal; irAEs: immune-related adverse events; CRS: cytokine release syndrome; IRRs: infusion related reactions.
  • ||||||||||  azacitidine / Generic mfg.
    Journal, CAR T-Cell Therapy, IO biomarker:  Demethylating therapy increases anti-CD123 CAR T cell cytotoxicity against acute myeloid leukemia. (Pubmed Central) -  Dec 16, 2021   
    Here, we develop third-generation anti-CD123 CAR T cells with a humanized CSL362-based ScFv and a CD28-OX40-CD3ζ intracellular signaling domain...CD123 expression on leukemia cells increases upon 5'-Azacitidine (AZA) treatment...Functionally, the CTLA-4 anti-CD123 CAR T cells exhibit superior cytotoxicity against AML cells, accompanied by higher TNFα production and enhanced downstream phosphorylation of key T cell activation molecules. Our findings indicate that AZA increases the immunogenicity of AML cells, enhancing recognition and elimination of malignant cells by highly efficient CTLA-4 anti-CD123 CAR T cells.
  • ||||||||||  talacotuzumab (JNJ-56022473) / J&J
    Clinical, Journal, Patient reported outcomes:  Patient-reported outcomes predict overall survival in older patients with acute myeloid leukemia. (Pubmed Central) -  Sep 16, 2021   
    P2/3
    Our findings indicate that AZA increases the immunogenicity of AML cells, enhancing recognition and elimination of malignant cells by highly efficient CTLA-4 anti-CD123 CAR T cells. These results indicate PROs' value for predicting outcomes among older AML patients and underscore the need to more systematically collect PRO data in routine care with these patients.
  • ||||||||||  Leustatin (cladribine) / J&J
    [VIRTUAL] Novel Combination Drug Regimens Using Hypomethylating Agents in Treatment of Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia () -  Nov 5, 2020 - Abstract #ASH2020ASH_4981;    
    In addition, three studies compared outcomes of CDR involving decitabine with all trans retinoic acid (ATRA)(n=93, ORR=21.9% vs 13.5%, p=0.06; mOS= 8.2 m vs 5.1 m, p=0.006) or talacotuzumab (CR/CRi= 15% vs 11%, p=0.44; mOS= 5.36 m vs 7.26 m, p=0.78) or bortezomib (CR/CRi= 39% vs 38%, p=0.91, mOS=9.3 m vs 8.9,p=0.18) to decitabine alone...Drugs included midostaurin (n= 88 , CR/CRi=25-29% mOS= 6-8 m) and pracinostat (n= 50, CR/CRi =46% mOS=19.1 m), In addition, two studies compared outcomes using CDR involving AZA with panobinostat (n=22, CR= 22.4 vs 30.8%, OS at 1 year = 60% vs 70%) or entinostat (n=18, ORR= 0% vs 16.6%, mOS=6 m vs 13 m) to AZA alone...The above listed efficacious CDR involving decitabine in phase I/II studies need to be evaluated in large, randomized trials to assess for definitive benefit. If proven efficacious in larger studies, they could serve as additional first line CDR options in addition to HMA and venetoclax in treating elderly patients with newly diagnosed AML.
  • ||||||||||  talacotuzumab (JNJ-56022473) / J&J
    Journal:  Development of a novel fully-human anti-CD123 antibody to target acute myeloid leukemia. (Pubmed Central) -  May 27, 2020   
    Further, the two antibodies, when reformatted as bispecific BiTE™ reagents by fusion with the anti-CD3 scFv(OKT3) antibody fragment, induced selective killing of AML blasts by patient-derived, autologous T-cells in an in vitro setting, but BiTE(CSL362/OKT3) exhibited a 10-fold higher potency compared to BiTE(H9/OKT3). The availability of two classes of CD123-specific biopharmaceuticals, capable of redirecting the cytolytic activity of NK cells and T cells against AML blasts, may enable novel interventional strategies and combination opportunities for the treatment of AML.
  • ||||||||||  azacitidine / Generic mfg.
    Azacytidine Sensitizes AML Cells for Effective Elimination By CD123 CAR T-Cells (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_5634;    
    Chimeric antigen receptor T-cells (CAR Tc) have yielded impressive remission rates in treatment-refractory B-cell malignancies (B-ALL and B-lymphomas) by targeting CD19, resulting in the first FDA approved CAR Tc therapies, Kymriah and Yescarta...The anti-CD123 CAR was constructed with the humanized CSL362-based ScFv and the CD28-OX40-CD3ζ signaling domain, encoded in a third-generation lentiviral vector and expressed in CD3+ Tc from healthy donors...This is the first demonstration that HMAs and CAR Tc immunotherapy can be used synergistically to treat AML. Considering HMAs are currently under clinical investigation in AML, our data encourage further clinical evaluation of this dual treatment in r/r AML, including high-risk patients that are chemotherapy or allogeneic transplantation ineligible.
  • ||||||||||  talacotuzumab (JNJ-56022473) / J&J
    Enrollment change, Trial termination, Trial primary completion date:  SAMBA: Single Agent JNJ-56022473 in MDS and AML Patients FAILING HYPOMETHYLATING AGENT BASED THERAPY (clinicaltrials.gov) -  Oct 25, 2018   
    P2,  N=25, Terminated, 
    Phase classification: P3 --> P2/3 N=43 --> 25 | Suspended --> Terminated | Trial primary completion date: Jun 2018 --> Oct 2018; Enrollement was stopped due to a recommendation by the IDMC/FDA for a parallel clinical trial with TALA, where potentielly no efficancy could be determined.
  • ||||||||||  talacotuzumab (JNJ-56022473) / J&J
    Enrollment closed, Trial primary completion date:  A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission (clinicaltrials.gov) -  Jul 2, 2015   
    P1,  N=36, Active, not recruiting, 
    Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2018 --> Mar 2017 Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2015 --> Dec 2015