Search the database for deliberate release of GM medicinal products
Displaying 1 - 5 of 5
| EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
|---|---|---|---|---|
| CP0201-NHL | A Phase I/II, multicenter study, evaluating the feasibility, safety, and efficacy of point-of-care manufactured 19CP02 in subjects with relapsed/refractory B-cell non-Hodglin lymphoma | CellPoint B.V. | Humans | CD19-CAR |
| B/BE/19/BVW4 | Importation of doses of V920 for Emergency Use | Merck Sharp & Dohme B.V. | Humans | Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene encoding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein (GP). |
| Only notified under the "contained use" procedure. Dossier submitted on 22/03/2016. | Phase I study to evaluate the safety and immunogenicity of a bivalent recombinant vaccine against human cytomegalovirus (HCMV). | Hookipa Biotech AG | Humans | Two replication-deficient lymphocytic choriomeningitidis virus (rLCMV) vectors, one expressing a truncated gBprotein of HCMV and one expressing the pp65 protein of the human CMV |
| Only notified under the "contained use" procedure. Dossier submitted on 14/10/2015. | A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia | Novartis Pharma Services AG | Humans | Chimeric antigen receptor against CD19 |
| B/BE/11/BVW2 | Clinical Study BNIT-PRV-301 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer | BN-Immunotherapeutics | Humans | Human gene coding for the prostate-specific antigen (PSA) and genes encoding 3 human immunological costimulatory molecules |