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- AV-GBM-1 / AiVita Biomedical
Final results of phase 2 trial of personal dendritic cell (DC) vaccines loaded with autologous tumor antigens (ATA) in newly diagnosed glioblastoma (GBM). (Available On Demand; Poster Bd # 404) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1080;
P2
PFS was encouraging, but did not translate into improved OS, perhaps because DC-ATA was limited to 8 injections. Clinical trial information: NCT03400917.
- |||| AV-GBM-1 / AiVita Biomedical
Trial completion date, Trial primary completion date, Surgery: AV-GBM-1 vs Control as Adjunctive Therapy Following Surgery and RT/TMZ in Newly Diagnosed GBM (clinicaltrials.gov) - Apr 10, 2023
P3, N=672, Not yet recruiting, Sponsor: Aivita Biomedical, Inc.
Clinical trial information: NCT03400917. Trial completion date: Mar 2027 --> Mar 2029 | Trial primary completion date: Mar 2026 --> Mar 2028
- || AV-GBM-1 / AiVita Biomedical
P2 data, Clinical Trial,Phase II, Journal: Phase 2 study of AV-GBM-1 (a tumor-initiating cell targeted dendritic cell vaccine) in newly diagnosed Glioblastoma patients: safety and efficacy assessment. (Pubmed Central) - Dec 16, 2022
P2
Treatment was well-tolerated, but there were numerous treatment-emergent central nervous system AEs. mPFS was longer than historical benchmarks, though no mOS improvement was noted.
- ovapuldencel-T (AVOVA-1) / Lisata Therap, AiVita Biomedical
Leukapheresis to obtain monocytes to produce dendritic cells for manufacturing AV-OVA-1 personal vaccines in a randomized phase II trial in patients with newly diagnosed advanced ovarian cancer (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_896;
P2
Trial Registration Clinicaltrials. gov NCT00331526 Ethics Approval This study was approved by the Western IRB, approval number 20171661; all participants gave written informed consent before taking part
- AV-GBM-1 / AiVita Biomedical
Seizures as treatment-emergent adverse events during glioblastoma clinical trials. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_4474;
The frequency of seizures that occur in GBM patients receiving standard RT/TMZ is not well-documented in publications of large, randomized trials. AV-GBM-1 may be associated with a higher rate of seizures because of treatment-induced inflammation at the tumor site, but a randomized trial would be needed to determine this.
- AV-GBM-1 / AiVita Biomedical
Plasma proteomic markers prognostic or predictive for survival of patients with newly diagnosed glioblastoma who were treated in a phase II trial with standard care and the addition of the novel patient-specific dendritic cell vaccine AV-GBM-1 (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_3960;
The only markers that appeared predictive for survival (p<0.05) based on changes from baseline to week-2 were increased lipocalin-2, associated with longer survival (p=0.0369), and decreased brain-derived neurotrophic factor (BDNF) associated with shorter survival (p=0.0186). Because of the large number of analyses, these results are considered hypothesis generating and not definitive.
- || AV-GBM-1 / AiVita Biomedical
Trial primary completion date, Surgery: Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma (clinicaltrials.gov) - Dec 16, 2021
P2, N=55, Active, not recruiting, Sponsor: Aivita Biomedical, Inc.
Because of the large number of analyses, these results are considered hypothesis generating and not definitive. Trial primary completion date: Jun 2021 --> Dec 2021
- AV-GBM-1 / AiVita Biomedical
PHASE II TRIAL OF VACCINE IMMUNOTHERAPY IN PRIMARY GLIOBLASTOMA: ADJUNCTIVE AUTOLOGOUS DENDRITIC CELLS PULSED WITH LYSATE FROM IRRADIATED SELF-RENEWING AUTOLOGOUS TUMOR CELLS (AV-GBM-1) () - Nov 16, 2021 - Abstract #SNO2021SNO_1215;
P2
A phase III trial is in development. Clinicaltrials.gov NCT03400917.
- temozolomide / Generic mfg.
Phase II trial of AV-GBM-1: dendritic cell vaccine pulsed with lysate enriched for autologous tumor-initiating cell antigens in the treatment of patients with newly diagnosed glioblastoma (Poster Hall) - Oct 31, 2021 - Abstract #SITC2021SITC_1295;
P2
PFS was very encouraging but did not translate into OS, perhaps because of discontinuation of treatment after 8 months. Trial Registration [Clinicaltrials.gov NCT03400917]
- |||||||||| AV-GBM-1 / AiVita Biomedical
New P3 trial, Surgery: AV-GBM-1 vs Control as Adjunctive Therapy Following Surgery and RT/TMZ in Newly Diagnosed GBM (clinicaltrials.gov) - Oct 28, 2021
P3, N=726, Not yet recruiting, Sponsor: Aivita Biomedical, Inc.
- temozolomide / Generic mfg.
Adverse events in a phase II trial of AV-GBM-1: dendritic cell vaccine pulsed with lysate enriched for autologous tumor-initiating cell antigens for patients with newly diagnosed glioblastoma (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_918;
P2
The high frequency of focal neurologic events may be secondary to local inflammation induced by AV-GBM-1. Clinicaltrials gov NCT03400917
- temozolomide / Generic mfg.
Tumor collection and establishment of tumor-initiating cell cultures as antigen source for AV-GBM-1 dendritic cell vaccines for a phase II trial in patients with newly diagnosed glioblastoma (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_916;
P2
Conclusions Self-renewing GBM TIC cultures can be reliably and rapidly established for use as the antigen source for personal DC-ATA vaccines. Clinicaltrials gov NCT03400917
- temozolomide / Generic mfg.
Leukaphereses to obtain monocytes to produce dendritic cells in manufacturing of personal autologous AV-GBM-1 vaccines in a phase II trial in patients with newly diagnosed glioblastoma (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_371;
P2
Success after a single leukapheresis was not related to the interval from surgery to pheresis procedure, or distance from the processing site. Clinicaltrials gov NCT03400917
- temozolomide / Generic mfg.
Changes in proteomic markers after injections of personal AV-GBM-1 dendritic cell/tumor initiating cell vaccines in a phase II trial in patients with newly diagnosed glioblastoma (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_370;
P2
More sophisticated analyses of this data set, such as principal component analysis, may be needed to understand the effects of AV-GBM-1. Clinicaltrials gov NCT03400917
- temozolomide / Generic mfg.
Tumor markers associated with increased survival in a phase II trial of dendritic cell/tumor-initiating-cell vaccine AV-GBM-1 in patients with newly diagnosed glioblastoma (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_369;
P2
Conclusions Both MGMT promotor methylation and IDH mutation were associated with a substantial and similar survival benefit in primary GBM patients treated with AV-GBM-1 in addition to standard aggressive therapy. Clinicaltrials gov NCT03400917
- || AV-GBM-1 / AiVita Biomedical
AV-GBM-1 Active in Frontline Glioblastoma https://t.co/xSdUqjqdLT (Twitter) - Apr 8, 2020
- || AV-GBM-1 / AiVita Biomedical
Enrollment closed, Trial completion date, Trial primary completion date, Surgery: Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma (clinicaltrials.gov) - Jan 27, 2020
P2, N=55, Active, not recruiting, Sponsor: Aivita Biomedical, Inc.
Clinicaltrials gov NCT03400917 Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Feb 2023 | Trial primary completion date: Oct 2020 --> Jun 2021
- | AV-GBM-1 / AiVita Biomedical
Enrollment open, Surgery: Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma (clinicaltrials.gov) - Jun 26, 2018
P2, N=55, Recruiting, Sponsor: Aivita Biomedical, Inc.
Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Feb 2023 | Trial primary completion date: Oct 2020 --> Jun 2021 Not yet recruiting --> Recruiting
- | AV-GBM-1 / AiVita Biomedical
Trial completion date, Trial primary completion date, Surgery: Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma (clinicaltrials.gov) - Mar 13, 2018
P2, N=55, Not yet recruiting, Sponsor: Aivita Biomedical, Inc.
Not yet recruiting --> Recruiting Trial completion date: Feb 2025 --> Apr 2023 | Trial primary completion date: Feb 2023 --> Oct 2020
- | AV-GBM-1 / AiVita Biomedical
New P2 trial, Surgery: Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma (clinicaltrials.gov) - Jan 17, 2018
P2, N=55, Not yet recruiting, Sponsor: Aivita Biomedical, Inc.