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DRUG:

AV-GBM-1

i
Other names: Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens, AV-GBM-1
Company:
AiVita Biomedical
Drug class:
Immunostimulant
Related drugs:
over1year
AV-GBM-1 vs Control as Adjunctive Therapy Following Surgery and RT/TMZ in Newly Diagnosed GBM (clinicaltrials.gov)
P3, N=672, Not yet recruiting, Aivita Biomedical, Inc. | Trial completion date: Mar 2027 --> Mar 2029 | Trial primary completion date: Mar 2026 --> Mar 2028
Trial completion date • Trial primary completion date • Surgery
|
MGMT (6-O-methylguanine-DNA methyltransferase)
|
temozolomide • AV-GBM-1
almost2years
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, J Exp Clin Cancer Res)
AV-GBM-1 was reliably manufactured. 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.
P2 data • Clinical Trial,Phase II • Journal
|
CSF2 (Colony stimulating factor 2)
|
temozolomide • AV-GBM-1
3years
P2 data • IO biomarker
|
MGMT (6-O-methylguanine-DNA methyltransferase) • CSF2 (Colony stimulating factor 2) • FGF (Fibroblast Growth Factor) • LCN2 (Lipocalin-2) • IL4 (Interleukin 4)
|
AV-GBM-1
3years
Clinical • New P3 trial
|
MGMT (6-O-methylguanine-DNA methyltransferase)
|
AV-GBM-1