- |||||||||| MesoPher (autologous dendritic cell vaccine) / Amphera
Trial completion date, Trial primary completion date: ENSURE: dENdritic Cell Therapy Combined With SURgEry in Mesothelioma (clinicaltrials.gov) - Apr 26, 2025 P1, N=16, Recruiting, Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
- |||||||||| Convalescent plasma therapy / Erasmus MC
Enrollment change, Trial termination: COVIC-19: Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19 (clinicaltrials.gov) - Oct 28, 2024 P3, N=120, Terminated, N=680 --> 120 | Recruiting --> Terminated; Due to the significant decline in the number of newly diagnosed infections and the difficulties in opening new centers in the outgoing pandemic, recruitment declined. The Data Safety Monitoring Board recommended to stop the trial.
- |||||||||| Convalescent plasma therapy / Erasmus MC
P1/2 data, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: Dosing of Convalescent Plasma and Hyperimmune Anti-SARS-CoV-2 Immunoglobulins: A Phase I/II Dose-Finding Study. (Pubmed Central) - Apr 26, 2024 Further randomised studies are needed of combinations of MesoPher and immune checkpoint therapy, which might increase efficacy without adding major toxicities. The results of this study may inform future intervention studies on the prophylactic and therapeutic use of antiviral antibodies in the form of ConvP or COVIg.
- |||||||||| MesoPher (autologous dendritic cell vaccine) / Erasmus MC, Amphera
Trial completion, Tumor cell: DENIM: DENdritic Cell Immunotherapy for Mesothelioma (clinicaltrials.gov) - Feb 1, 2024 P2/3, N=176, Completed, The results of this study may inform future intervention studies on the prophylactic and therapeutic use of antiviral antibodies in the form of ConvP or COVIg. Recruiting --> Completed
- |||||||||| MesoPher (autologous dendritic cell vaccine) / Erasmus MC, Amphera, mitazalimab (ADC-1013) / Alligator Biosci
Trial completion, Trial completion date, Trial primary completion date, IO biomarker: MesoPher/Mitazalimab-combination Therapy in Metastatic Pancreatic Disease (REACtiVe-2 Trial) (clinicaltrials.gov) - Oct 12, 2023 P1, N=22, Completed, Recruiting --> Completed Recruiting --> Completed | Trial completion date: Oct 2023 --> May 2023 | Trial primary completion date: Oct 2023 --> May 2023
- |||||||||| MesoPher (autologous dendritic cell vaccine) / Erasmus MC, Amphera
Dendritic Cell Immunotherapy Versus Best Supportive Care as Maintenance Treatment in Patients with Pleural Mesothelioma (Summit 2) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_963; Likely the long interval between chemotherapy and the start of treatment caused that most patients had already disease progression before or during the first 3 DC treatments, prohibiting the induction of an effective immune response. This interval was extended compared to earlier MesoPher studies because randomization and additional sterility tests.
- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie
Clinical, P1 data, PK/PD data, Journal: Phase 1 study of safety, pharmacokinetics, and antiviral activity of SARS-CoV-2 neutralizing monoclonal antibody ABBV-47D11 in patients with COVID-19. (Pubmed Central) - Dec 21, 2022 The exploratory anti-SARS-CoV-2 activity revealed a reduction of viral load at and above the 600 mg dose of ABBV-47D11 regardless of patient demographics and baseline characteristics, however; because of the high inter-individual variability and small sample size a statistical significance was not reached. There is potential for anti-SARS-CoV-2 activity with ABBV-47D11 doses of 600 mg or higher, which could be evaluated in future clinical trials designed and powered to assess viral load reductions and clinical benefit.
- |||||||||| Convalescent plasma therapy / Erasmus MC
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study) (clinicaltrials.gov) - Apr 1, 2022 P3, N=420, Terminated, N=426 --> 86 | Active, not recruiting --> Terminated; new insights into COVID19 pathogenesis N=690 --> 420 | Trial completion date: Nov 2023 --> Mar 2022 | Recruiting --> Terminated | Trial primary completion date: Nov 2022 --> Oct 2021; vaccination uptake 80% in the target population/new COVID variant
- |||||||||| Convalescent plasma therapy / Erasmus MC
Journal: Interferon-α2 Auto-antibodies in Convalescent Plasma Therapy for COVID-19. (Pubmed Central) - Feb 19, 2022 The presence of neutralizing IFN-α2 Abs in critically ill COVID-19 is associated with delayed viral clearance. IFN-α2 Abs in COVID-19 convalescent plasma donors were not neutralizing in the conditions tested.
- |||||||||| Convalescent plasma therapy / Erasmus MC
Journal: Lessons learned in the collection of convalescent plasma during the COVID-19 pandemic. (Pubmed Central) - Oct 20, 2021 The need for flexibility and adaptability remains paramount when dealing with a pandemic. As the world approaches the first anniversary of the COVID-19 pandemic with rising rates worldwide and over 115 million cases and 2·55 million deaths, respectively, it is important to reflect on how to better prepare for future pandemics as we continue to combat the current one.
- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie, ABBV-2B04 / AbbVie
Trial completion, Adverse events, Combination therapy, Monotherapy: Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - Sep 2, 2021 P1, N=25, Completed, As the world approaches the first anniversary of the COVID-19 pandemic with rising rates worldwide and over 115 million cases and 2·55 million deaths, respectively, it is important to reflect on how to better prepare for future pandemics as we continue to combat the current one. Active, not recruiting --> Completed
- |||||||||| Preclinical, Journal: In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains. (Pubmed Central) - Aug 12, 2021
When administered after infection as therapy, higher doses of several mAb cocktails protected in vivo against viruses with a B.1.351 spike gene. Thus, many, but not all, of the antibody products with Emergency Use Authorization (EUA) should retain substantial efficacy against the prevailing SARS-CoV-2 variant strains.
- |||||||||| Convalescent plasma therapy / Erasmus MC
Preclinical, Journal: SARS-CoV-2 neutralizing human antibodies protect against lower respiratory tract disease in a hamster model. (Pubmed Central) - Jun 24, 2021 These data highlight the importance of screening plasma donors for high levels of neutralizing antibodies. Our data show that prophylactic administration of high levels of neutralizing antibody, either monoclonal or from convalescent plasma, prevent severe SARS-CoV-2 pneumonia in a hamster model, and could be used as an alternative or complementary to other antiviral treatments for COVID-19.
- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie, ABBV-2B04 / AbbVie
Enrollment closed, Enrollment change, Adverse events, Combination therapy, Monotherapy: Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - May 19, 2021 P1, N=24, Active, not recruiting, Treatment with convalescent plasma should be studied early in the disease course or at least preceding autologous humoral response development. Recruiting --> Active, not recruiting | N=54 --> 24
- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie, ABBV-2B04 / AbbVie
Enrollment change, Adverse events, Combination therapy, Monotherapy: Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - Mar 15, 2021 P1, N=54, Recruiting, In our opinion, these findings show the potency of DC vaccination therapy in long-term activation of the immune system . N=24 --> 54
- |||||||||| MesoPher (autologous dendritic cell vaccine) / Erasmus MC, Amphera
Trial completion date, Trial primary completion date, Tumor cell: DENIM: DENdritic Cell Immunotherapy for Mesothelioma (clinicaltrials.gov) - Jan 27, 2021 P2/3, N=230, Recruiting, N=24 --> 54 Trial completion date: Jan 2021 --> Feb 2023 | Trial primary completion date: Jan 2021 --> Feb 2023
- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie, ABBV-2B04 / AbbVie
Enrollment open, Enrollment change, Adverse events, Combination therapy, Monotherapy: Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - Dec 17, 2020 P1, N=32, Recruiting, Trial completion date: Jan 2021 --> Feb 2023 | Trial primary completion date: Jan 2021 --> Feb 2023 Not yet recruiting --> Recruiting | N=24 --> 32
- |||||||||| HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie, ABBV-2B04 / AbbVie
New P1 trial, Adverse events, Combination therapy, Monotherapy: Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - Nov 24, 2020 P1, N=24, Not yet recruiting,
- |||||||||| Convalescent plasma therapy / Erasmus MC
Enrollment closed, Trial completion date, Trial primary completion date: Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study) (clinicaltrials.gov) - Nov 16, 2020 P2/3, N=426, Active, not recruiting, Not yet recruiting --> Recruiting | N=24 --> 32 Recruiting --> Active, not recruiting | Trial completion date: Jul 2020 --> Jul 2021 | Trial primary completion date: Jul 2020 --> Jul 2021
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