Search the database for deliberate release of GM medicinal products
Displaying 1 - 6 of 6
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
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ADP-0055-001 | A phase I, ascending dose, to evaluate safety and efficacy of ADP A2M4CD8 in HLA-A2+ patients with MAGE-A4 psoitives tumors | Adaptimmune LLC | Humans | MAGE-A4 specific T cell receptor (TCR) with a CD8α co-receptor |
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018. | A Phase 2a Randomized, Double-blind, Placebo-controlled rial to Assess the safety, Immunogenicity, and Efficacy of the Recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Volunteers | Bavarian Nordic A/S | Humans | Vaccinia virus Ankara strain expression glycoproteins of different RSV strain (MVA-BN) |
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 |
Only notified under the "contained use" procedure. Dossier submitted on 02/01/1996. | Gene therapy for the treatment of glioblastoma multiforme with in vivo tumor transduction with the herpes simplex thymidine kinase gene /ganciclovir system | Sandoz Pharma, LTD | Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR) |