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32 Diseases |  |
1 Trial |
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1 Trial |  |
58 News |  |
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Journal: Hu14.18K.322A Causes Direct Cell Cytotoxicity and Synergizes with Induction Chemotherapy in High-Risk Neuroblastoma. (Pubmed Central) - Jun 19, 2024
In this study, we examined the direct cytotoxic effects of the humanized anti-GD2 antibody hu14.18K322A (hu14) on NB cell lines, by exploring the associated cell-death pathways...Our comprehensive investigation provides valuable insights into the multifaceted effects of hu14 on NB cells, shedding light on its direct cytotoxicity, cell-death pathways, and interactions with induction chemotherapy drugs. This study contributes to the evolving understanding of anti-GD2 antibody therapy and its potential synergies with conventional treatments in the context of NB.
- Leukine (sargramostim) / Partner Therap, humanised dinutuximab (Hu14.18K322A) / Essential Pharma, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
A pilot study of post-consolidation chemoimmunotherapy for high-risk neuroblastoma (ANBL19P1): A report from the Children's Oncology Group. (S100bc) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2740;
P2
Administration of post-consolidation chemoimmunotherapy in pts who underwent tandem ASCT is tolerable and met pre-defined feasibility criteria. The impact of this approach on survival outcomes will be studied in a future COG trial.
- humanised dinutuximab (Hu14.18K322A) / Renaissance Pharma
Direct cytotoxicity of hu14.18K.322A in high-risk neuroblastoma (Section 9) - Mar 5, 2024 - Abstract #AACR2024AACR_8622;
Taken together, our findings suggest that hu14.18K322A induces direct cell cytotoxicity in a subset of high-risk Neuroblastoma and synergizes well with standard chemotherapy drugs. Furthermore, our research highlights the complex nature of signaling pathways involved in hu14-mediated cytotoxicity that can be harnessed towards targeted therapy.
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial completion date, Metastases: Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - Jan 16, 2024
P2, N=153, Active, not recruiting, Sponsor: St. Jude Children's Research Hospital
Furthermore, our research highlights the complex nature of signaling pathways involved in hu14-mediated cytotoxicity that can be harnessed towards targeted therapy. Trial completion date: Dec 2023 --> Dec 2024
- humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital
A multicenter cooperative group study of late effects after high-risk neuroblastoma: COG ALTE15N2 (Live Stream | S100a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3195;
The burden of late toxicity in HRNBL survivors is substantial. Anti-GD2 immunotherapy and isotretinoin do not appear to be associated with SMN, ototoxicity, growth failure, or RLD.
- | humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital
Preclinical, Journal, IO biomarker: Mesenchymal and adrenergic cell lineage states in neuroblastoma possess distinct immunogenic phenotypes. (Pubmed Central) - Oct 26, 2022
Mesenchymal lineage cells promote T cell infiltration by secreting inflammatory cytokines, are efficiently targeted by cytotoxic T and natural killer cells and respond to immune checkpoint blockade. Together, we demonstrate that distinct immunogenic phenotypes define the divergent lineage states of neuroblastoma and highlight the immunogenic potential of the mesenchymal lineage.
- | humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital
Journal: Global Neuroblastoma Network: An international multidisciplinary neuroblastoma tumor board for resource-limited countries. (Pubmed Central) - May 6, 2022
Together, we demonstrate that distinct immunogenic phenotypes define the divergent lineage states of neuroblastoma and highlight the immunogenic potential of the mesenchymal lineage. This report shows the utility of an international tumor board for LMIC focused on a challenging solid tumor where local expertise may be limited, with international multidisciplinary expert participation and educational sessions.
- || humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital
Clinical, P2 data, Journal: Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A. (Pubmed Central) - Feb 22, 2022
Adding hu14.18K322A to induction chemotherapy improved early objective responses, significantly reduced tumor volumes in most patients, improved end-of-induction response rates, and yielded an encouraging 3-year EFS. These results, if validated in a larger study, may be practice changing.
- | humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital, Unituxin (dinutuximab) / United Therapeutics Corp
This improved, genetically modified version of Unituxan (dinutuximab), an approved monoclonal antibody (mAb) targeting the disialoganglioside GD2. It has a significantly better tolerance profile and is known as hu14.18K322A, which improved survival rates and outcomes. (Twitter) - Jan 28, 2022
- |||| humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital
Anti-GD2 monoclonal antibody hu14.18K322A with induction chemotherapy improves outcomes in high-risk #neuroblastoma 👉 https://t.co/8jInta5Poa #JCO #pedcsm @SaraFedericoMD (Twitter) - Dec 14, 2021
- || humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital, Unituxin (dinutuximab) / United Therapeutics Corp
Clinical, Journal: Pre-existing antitherapeutic antibodies against the Fc region of the hu14.18K322A mAb are associated with outcome in patients with relapsed neuroblastoma. (Pubmed Central) - Sep 2, 2021
P1
This study demonstrates an association between clinical outcome and the presence of PATA against determinant(s) on the Fc component of the therapeutic mAb, suggesting that the PATA may be playing a role in augmenting mAb-based antitumor effects. Further analyses for the presence of PATA in a larger cohort of patients with relapsed neuroblastoma, analyses of their clinical correlates, identification of their immunological targets, and potential antitumor mechanisms are warranted.
- || humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital
P1 data, PK/PD data, Journal: A Phase 1 and pharmacokinetic study evaluating daily or weekly schedules of the humanized anti-GD2 antibody hu14.18K322A in recurrent/refractory solid tumors. (Pubmed Central) - Jul 7, 2021
The recommended dose for patients with osteosarcoma receiving daily hu14.18K322A x4 is 60 mg/m. Patients receiving the weekly schedule experienced similar pharmacokinetics and toxicity profile as the daily schedule.
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial completion date, Trial primary completion date, Metastases: Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - Feb 24, 2021
P2, N=153, Active, not recruiting, Sponsor: St. Jude Children's Research Hospital
Patients receiving the weekly schedule experienced similar pharmacokinetics and toxicity profile as the daily schedule. Trial completion date: Jul 2021 --> Dec 2023 | Trial primary completion date: Jan 2021 --> Dec 2021
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial completion, Trial completion date: Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody (clinicaltrials.gov) - Nov 5, 2020
P=N/A, N=76, Completed, Sponsor: St. Jude Children's Research Hospital
Trial completion date: Jul 2021 --> Dec 2023 | Trial primary completion date: Jan 2021 --> Dec 2021 Active, not recruiting --> Completed | Trial completion date: Oct 2020 --> Apr 2020
- || humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital
Clinical, P2 data, Journal, Combination therapy: A Phase II Trial of Hu14.18K322A in Combination with Induction Chemotherapy in Children with Newly Diagnosed High-Risk Neuroblastoma. (Pubmed Central) - Sep 9, 2020
Adding hu14.18K322A to induction chemotherapy produced early PR or better in most patients, reduced tumor volumes, improved CSs at the end of induction, and yielded an encouraging 2-year EFS. These results, if validated in a larger study, may change the standard of care for children with high-risk neuroblastoma.
- || Hu14.18K322A / St. Jude Children's Research Hospital
Clinical, Journal: Correction: Pre-existing antitherapeutic antibodies against the Fc region of the hu14.18K322A mAb are associated with outcome in patients with relapsed neuroblastoma. (Pubmed Central) - Jun 27, 2020
These results, if validated in a larger study, may change the standard of care for children with high-risk neuroblastoma. No abstract available
- | Hu14.18K322A / St. Jude Children's Research Hospital
Journal, IO Biomarker: Positron Emission Tomography Detects In Vivo Expression of Disialoganglioside GD2 in Mouse Models of Primary and Metastatic Osteosarcoma. (Pubmed Central) - Mar 14, 2020
To address these limitations, we evaluated a novel, sensitive radiotracer [Cu]Cu-Bn-NOTA-hu14.18K322A to detect GD2 expression in osteosarcomas (six patient-derived xenografts and one cell line) in vivo using positron emission tomography (PET)...Radiolabeled antibody accumulation in patient-derived xenografts correlated with GD2 expression as measured by flow cytometry (Pearson r =0.88, p =0.01), distinguishing moderately GD2-expressing osteosarcomas (32-69% GD2-positive cells) from high GD2-expressors (>99%, p <0.05). These results support the utility of GD2 imaging with PET to measure GD2 expression in osteosarcoma and thus maximize the clinical impact of anti-GD2 immunotherapy.
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial completion date: Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody (clinicaltrials.gov) - Mar 12, 2020
P=N/A, N=76, Active, not recruiting, Sponsor: St. Jude Children's Research Hospital
These results support the utility of GD2 imaging with PET to measure GD2 expression in osteosarcoma and thus maximize the clinical impact of anti-GD2 immunotherapy. Trial completion date: Feb 2020 --> Oct 2020
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Enrollment closed: Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody (clinicaltrials.gov) - Nov 7, 2019
P=N/A, N=76, Active, not recruiting, Sponsor: St. Jude Children's Research Hospital
Trial completion date: Feb 2020 --> Oct 2020 Recruiting --> Active, not recruiting
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Enrollment closed, Metastases: Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - Oct 16, 2019
P2, N=153, Active, not recruiting, Sponsor: St. Jude Children's Research Hospital
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial completion: Combination Chemotherapy, Monoclonal Antibody, and Natural Killer Cells in Treating Young Patients With Recurrent or Refractory Neuroblastoma (clinicaltrials.gov) - Nov 15, 2018
P1, N=34, Completed, Sponsor: St. Jude Children's Research Hospital
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital
Clinical, Journal: A pilot trial of humanized anti-GD2 monoclonal antibody (hu14.18K322A) with chemotherapy and natural killer cells in children with recurrent/refractory neuroblastoma. (Pubmed Central) - Jul 25, 2018
Chemotherapy plus hu14.18K322A, cytokines and NK cells is feasible and resulted in clinically meaningful responses in patients with refractory/recurrent neuroblastoma. Further studies of this approach are warranted in patients with relapsed and newly-diagnosed neuroblastoma.
- | melphalan / Generic mfg.
Journal: Consolidation Therapy for Newly Diagnosed Pediatric High-Risk Neuroblastoma Patients Using Busulfan/Melphalan, Autologous Hematopoietic Cell Transplant, Anti-GD2 Antibody, GM-CSF, IL-2 and Haploidentical NK Cells. (Pubmed Central) - Jun 29, 2018
Toxicities were similar for patients that did or did not receive NKs. We conclude that this consolidation regimen is feasible and has an acceptable acute toxicity profile.
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial completion date: Combination Chemotherapy, Monoclonal Antibody, and Natural Killer Cells in Treating Young Patients With Recurrent or Refractory Neuroblastoma (clinicaltrials.gov) - Mar 3, 2018
P1, N=34, Active, not recruiting, Sponsor: St. Jude Children's Research Hospital
We conclude that this consolidation regimen is feasible and has an acceptable acute toxicity profile. Trial completion date: Feb 2019 --> Oct 2018
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial completion, Enrollment change, Trial primary completion date: A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas (clinicaltrials.gov) - Dec 22, 2017
P1, N=8, Completed, Sponsor: St. Jude Children's Research Hospital
Trial completion date: Feb 2019 --> Oct 2018 Recruiting --> Completed | N=36 --> 8 | Trial primary completion date: Sep 2020 --> Dec 2017
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial completion, Trial primary completion date: A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma (clinicaltrials.gov) - Aug 17, 2017
P1, N=50, Completed, Sponsor: St. Jude Children's Research Hospital
Recruiting --> Completed | N=36 --> 8 | Trial primary completion date: Sep 2020 --> Dec 2017 Active, not recruiting --> Completed | Trial primary completion date: Jun 2017 --> Apr 2014
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Enrollment change, Metastases: Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - Sep 7, 2016
P2, N=210, Recruiting, Sponsor: St. Jude Children's Research Hospital
Active, not recruiting --> Completed | Trial primary completion date: Jun 2017 --> Apr 2014 N=150 --> 210
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Enrollment closed, Enrollment change: A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma (clinicaltrials.gov) - Aug 19, 2016
P1, N=50, Active, not recruiting, Sponsor: St. Jude Children's Research Hospital
N=150 --> 210 Recruiting --> Active, not recruiting | N=75 --> 50
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial primary completion date, Metastases: Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - Aug 8, 2016
P2, N=150, Recruiting, Sponsor: St. Jude Children's Research Hospital
Recruiting --> Active, not recruiting | N=75 --> 50 Trial primary completion date: Sep 2018 --> Jan 2021
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Enrollment change, Metastases: Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - Apr 11, 2016
P2, N=150, Recruiting, Sponsor: St. Jude Children's Research Hospital
Trial primary completion date: Sep 2018 --> Jan 2021 N=42 --> 150
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial primary completion date: A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma (clinicaltrials.gov) - Feb 4, 2016
P1, N=75, Recruiting, Sponsor: St. Jude Children's Research Hospital
N=42 --> 150 Trial primary completion date: Jun 2016 --> Jun 2017
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Phase classification, Enrollment change: Combination Chemotherapy, Monoclonal Antibody, and Natural Killer Cells in Treating Young Patients With Recurrent or Refractory Neuroblastoma (clinicaltrials.gov) - Feb 3, 2016
P1, N=34, Active, not recruiting, Sponsor: St. Jude Children's Research Hospital
Trial primary completion date: Jun 2016 --> Jun 2017 Phase classification: P=N/A --> P1 | N=20 --> 34
- || humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial primary completion date: A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma (clinicaltrials.gov) - Aug 13, 2015
P1, N=75, Recruiting, Sponsor: St. Jude Children's Research Hospital
Phase classification: P=N/A --> P1 | N=20 --> 34 Trial primary completion date: Jun 2015 --> Jun 2016
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Enrollment closed: Combination Chemotherapy, Monoclonal Antibody, and Natural Killer Cells in Treating Young Patients With Recurrent or Refractory Neuroblastoma (clinicaltrials.gov) - Feb 27, 2015
P=N/A, N=20, Active, not recruiting, Sponsor: St. Jude Children's Research Hospital
Trial primary completion date: Jun 2015 --> Jun 2016 Recruiting --> Active, not recruiting
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Enrollment open, Trial initiation date, Trial primary completion date: A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas (clinicaltrials.gov) - Sep 22, 2014
P1, N=36, Recruiting, Sponsor: St. Jude Children's Research Hospital
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Initiation date: May 2014 --> Sep 2014 | Trial primary completion date: May 2020 --> Sep 2020
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Enrollment open: Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody (clinicaltrials.gov) - Jul 12, 2014
P=N/A, N=100, Recruiting, Sponsor: St. Jude Children's Research Hospital
Not yet recruiting --> Recruiting | Initiation date: May 2014 --> Sep 2014 | Trial primary completion date: May 2020 --> Sep 2020 Not yet recruiting --> Recruiting
- humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital
Clinical: Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody (clinicaltrials.gov) - Jun 4, 2014
P=N/A, N=100, Not yet recruiting, Sponsor: St. Jude Children's Research Hospital
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
New P1 trial: A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas (clinicaltrials.gov) - May 4, 2014
P1, N=36, Not yet recruiting, Sponsor: St. Jude Children's Research Hospital
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Enrollment change, Metastases: Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - Jun 3, 2013
P2, N=42, Recruiting, Sponsor: St. Jude Children's Research Hospital
Not yet recruiting --> Recruiting N=110 --> 42
- humanised dinutuximab (Hu14.18K322A) / Renaissance Pharma
Enrollment open, Metastases: Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - Jun 3, 2013
P2, N=42, Recruiting, Sponsor: St. Jude Children's Research Hospital
N=110 --> 42 Not yet recruiting --> Recruiting
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
New P2 trial, Metastases: Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - May 16, 2013
P2, N=42, Recruiting, Sponsor: St. Jude Children's Research Hospital
- humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Enrollment change: A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma (clinicaltrials.gov) - Jul 19, 2012
P1, N=75, Recruiting, Sponsor: St. Jude Children's Research Hospital
Not yet recruiting --> Recruiting N=45 --> 75
- humanised dinutuximab (Hu14.18K322A) / St. Jude Children's Research Hospital
Clinical: Combination Chemotherapy, Monoclonal Antibody, and Natural Killer Cells in Treating Young Patients With Recurrent or Refractory Neuroblastoma (clinicaltrials.gov) - Apr 10, 2012
P=N/A, N=20, Recruiting, Sponsor: St. Jude Children's Research Hospital