Blincyto (blinatumomab) / Astellas, Amgen 
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 29 Diseases   85 Trials   85 Trials   3645 News 


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  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Review, Journal:  Bispecific Antibodies and Other Non-CAR Targeted Therapies and HSCT: Decreased Toxicity for Better Transplant Outcome in Paediatric ALL? (Pubmed Central) -  Mar 8, 2022   
    Specific issues to be addressed include: (1) The use of these agents to reduce measurable residual disease (MRD) prior to HSCT and their potential for improved transplant outcomes due to reduced toxicity compared to traditional chemotherapy salvage, as well as potentially increased toxicity with HSCT with particular agents; (2) the appropriate sequencing of innovative therapies, i.e., when to use BiTEs or antibodies versus CARs pre- and/or post-HSCT; this will include also the potential for impact on response of one group of agents on response to the other; (3) the role of these agents particularly in the post-HSCT relapse setting, or as maintenance to prevent relapse in this setting; (4) special populations in which these agents may substitute for traditional chemotherapy during induction or consolidation in patients with predisposing factors for toxicity with traditional therapy (e.g., Trisomy 21, infants), or those who develop infectious complications precluding delivery of full standard-of-care (SOC) chemotherapy during induction/consolidation (e.g., fungal infections); (5) the evidence we have to date regarding the potential for substitution of blinatumomab for some of the standard chemotherapy agents used pre-HSCT in patients without the above risk factors for toxicity, but with high risk disease going into transplant, in an attempt to decrease current rates of transplant-related mortality as well as morbidity; (6) the unique toxicity profile of these agents and concerns regarding particular side effects in the HSCT context. The manuscript will include both the data we have to date regarding the above issues, ongoing studies that are trying to explore them, and suggestions for future studies to further refine our knowledge base.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Enrollment open, Minimal residual disease:  Blinatumomab in Pediatric B-cell Acute Lymphoblastic Leukemia (ALL) With Minimal Residual Disease (MRD) (clinicaltrials.gov) -  Mar 8, 2022   
    P1,  N=20, Recruiting, 
    The manuscript will include both the data we have to date regarding the above issues, ongoing studies that are trying to explore them, and suggestions for future studies to further refine our knowledge base. Not yet recruiting --> Recruiting
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Opdivo (nivolumab) / BMS, Imbruvica (ibrutinib) / AbbVie, J&J
    Trial completion:  Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation (clinicaltrials.gov) -  Mar 7, 2022   
    P2,  N=10, Completed, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Completed
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Marqibo (vincristine liposomal) / Servier, Aurobindo
    Enrollment change, Trial withdrawal:  Blincyto Amgen Acrotech BioPharma PH2 Blincyto Marqibo R/R Philadelphi CD19+ ALL (clinicaltrials.gov) -  Mar 2, 2022   
    P2,  N=0, Withdrawn, 
    Active, not recruiting --> Completed N=35 --> 0 | Suspended --> Withdrawn
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Anti-CD19-CAR / Beijing Doing Biomedical
    Journal, IO biomarker:  Factors associated with treatment response to CD19 CAR-T therapy among a large cohort of B cell acute lymphoblastic leukemia. (Pubmed Central) -  Mar 1, 2022   
    P1, P1/2
    Our data showed that TP53 mutation, bone marrow blasts > 20%, prior CAR-T/blinatumomab treatment, and severe cytokine release syndrome (CRS) were associated with a lower complete remission (CR) rate while age, extramedullary disease, complex cytogenetics, history of prior transplant, prior courses of chemotherapy, CAR-T cell dose, and manufacturing source of the cellular product did not affect patients' CR rate...Précis TP53 mutation and BM blasts > 20% are two independent factors associated with the CR rate. Patients with high tumor burden as well as those with bone marrow blasts < 5% can benefit from consolidative allo-HSCT post-CAR-T therapy.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Review, Journal:  The Role of Bispecific Antibodies in Non-Hodgkin's Lymphoma: From Structure to Prospective Clinical Use. (Pubmed Central) -  Mar 1, 2022   
    More specifically, they have elicited a great interest in the setting of non-Hodgkin's lymphoma (NHLs), where they could represent a viable option for more fragile patients or those resistant to other conventional therapies. This review aims to give a brief overview of the different available bsAb formats and their mechanisms of action, pinpointing the differences between IgG-like and non-IgG-like classes and will then focus on those in advanced clinical development for NHLs.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Blinatumomab: Love it or leave it? (Anaheim Convention Center - Learning Hall: Poster Pavilion) -  Feb 25, 2022 - Abstract #ONS2022ONS_292;    
    Of the 45 patients, 43 had a complete response and went to transplant. Blinatumomab we love it!!
  • ||||||||||  methotrexate / Generic mfg.
    Clinical, Journal:  Managing therapy-associated neurotoxicity in children with ALL. (Pubmed Central) -  Feb 22, 2022   
    Anticytokine therapies targeted to the pathophysiology of ICANS are in development. By using illustrative patient cases, we discuss the management of neurotoxicity from methotrexate, CAR T cells, and blinatumomab in this review.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Minimal residual disease:  OZM-097: Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant (clinicaltrials.gov) -  Feb 21, 2022   
    P2,  N=8, Terminated, 
    By using illustrative patient cases, we discuss the management of neurotoxicity from methotrexate, CAR T cells, and blinatumomab in this review. N=50 --> 8 | Trial completion date: Sep 2026 --> Feb 2022 | Recruiting --> Terminated | Trial primary completion date: Sep 2022 --> Feb 2022; Slow enrolment, loss of funding
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Clinical, Journal:  Acute lymphoblastic leukemia in older adults: curtain call for conventional chemotherapy? (Pubmed Central) -  Feb 19, 2022   
    Frontline treatment regimens for older adults using novel therapeutics with reduction or omission of conventional chemotherapy are being developed with early results demonstrating high remission rates and lower toxicity, but long-term efficacy and toxicity data are lacking. Collaboration between academic and pharmaceutical stakeholders is needed to develop clinical trials to define the optimal treatment regimens for older adults with ALL.
  • ||||||||||  imatinib / Generic mfg.
    Clinical, Clinical data, Journal:  Clinical Outcomes of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia in a County Hospital System. (Pubmed Central) -  Feb 17, 2022   
    Collaboration between academic and pharmaceutical stakeholders is needed to develop clinical trials to define the optimal treatment regimens for older adults with ALL. Addressing barriers raised by socioeconomic disparities, increasing access to effective therapies, and including patients with ALL treated in the community in clinical trials may improve survival for underserved populations.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Journal:  Bispecific antibody-activated T cells enhance NK cell-mediated antibody-dependent cellular cytotoxicity. (Pubmed Central) -  Feb 8, 2022   
    Brief (4 h to 2 day) bsAb exposure was sufficient to enhance long-term ADCC by NK cells. These findings raise the hypothesis that local T cell activation mediated by systemic treatment with anti-CD3 X anti-cancer bsAb may enhance the anti-tumor efficacy of monospecific mAbs that mediate their primary therapeutic effect via NK-mediated ADCC.
  • ||||||||||  Nailike (olverembatinib) / Ascentage Pharma, Takeda
    Enrollment change, Trial completion date, Trial primary completion date:  HQP1351CU101: Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL (clinicaltrials.gov) -  Feb 8, 2022   
    P1,  N=62, Recruiting, 
    These findings raise the hypothesis that local T cell activation mediated by systemic treatment with anti-CD3 X anti-cancer bsAb may enhance the anti-tumor efficacy of monospecific mAbs that mediate their primary therapeutic effect via NK-mediated ADCC. N=30 --> 62 | Trial completion date: Jun 2023 --> Jan 2024 | Trial primary completion date: Jun 2022 --> Jan 2023
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Rituxan (rituximab) / Roche
    Enrollment closed:  BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation (clinicaltrials.gov) -  Feb 8, 2022   
    P2,  N=41, Active, not recruiting, 
    N=30 --> 62 | Trial completion date: Jun 2023 --> Jan 2024 | Trial primary completion date: Jun 2022 --> Jan 2023 Recruiting --> Active, not recruiting
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    ROVER: REDIRECTOR OF VACCINE-INDUCED EFFECTOR RESPONSES FOR HIV-1 TARGET CELL KILLING ([VIRTUAL]) -  Feb 7, 2022 - Abstract #CROI2022CROI_873;    
    P4
    In cell killing assays, the ability of RoVER to mediate killing of target cells upon exposure to CTLs obtained from study participants 21 days post vaccination was assessed and compared to an FDA approved CD19 BiTE; blinatumomab...Advantages of this novel technology are that it obviates the need for ex vivo modification and expansion. Moreover, this technology is highly specific and easily adapted to recognize any cell surface antigen of interest and thus holds great promise for various diseases.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    DRIVING CELL THERAPY IN TREATMENT OF MRD-POSITIVE ACUTE PEDIATRIC LYMPHOBLASTIC LEUKEMIA AFTER ALLOGENEIC-SCT: BLINATUMOMAB + DLI (ePoster Area [VIRTUAL]) -  Jan 30, 2022 - Abstract #EBMT2022EBMT_1788;    
    The use of blinatumomab allowed recruitment of fit donor-derived T lymphocytes (not exposed to immune suppressive agents) against ALL B cells. This hypothesis is supported by the fact that patient 1, who received blinatumomab pre-HSCT and had disease progression, (probably due to lack of T cells showed by flow cytometry), achieved MRD-negative response after receiving DLI+ blinatumomab post transplant. All patients reached MRD-negative status and 2 subsequently developed CNS relapse; none received CNS prophylaxis post-HSCT.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    SY21. CAR T and BiTE: Finally Ready for Solid Tumors? (New Orleans Theater B, Convention Center) -  Jan 28, 2022 - Abstract #AACR2022AACR_896;    
    CD3-directed bispecific antibodies that recruit and redirect T cells to attack tumor cells have been successfully developed for blood cancers [i.e., Blinatumomab, a CD3xCD19 BsAb, approved in 2014 for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)]...Experimentation with half-life extension to promote longer persistence will be reviewed, as well as clinical data in prostate cancer and small cell lung cancer. Best practices for management of CRS and neurotoxicity will also be discussed.
  • ||||||||||  TNB-486 / TeneoTwo, Inc, Ancora Biotech
    Preclinical, Journal:  TNB-486 induces potent tumor cell cytotoxicity coupled with low cytokine release in preclinical models of B-NHL. (Pubmed Central) -  Jan 20, 2022   
    Additionally, the PK of TNB-486 in mice or cynomolgus monkeys is similar to conventional antibodies. This new T cell engaging bispecific antibody targeting CD19 represents a novel therapeutic that induces potent T cell-mediated tumor-cell cytotoxicity uncoupled from high levels of cytokine release, making it an attractive candidate for B-NHL therapy.