Search the database for deliberate release of GM medicinal products
Displaying 1 - 8 of 8
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
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B/BE/21/BVW7 | Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors | SCS Boehringer Ingelheim Comm.V | Humans | BI 1831169 is a recombinant live-attenuated Vesicular Stomatitis Virus (rVSV), modified to replace the VSV-G glycoprotein with the Lymphocytic Choriomeningitis Virus glycoprotein in order to minimize the potential of neurotoxicity for humans and skin disease in animals. |
Only notified under the "contained use" procedure. Dossier submitted on 18/02/2020. | A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults | Themis Bioscience GmbH | Humans | Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV |
Only notified under the "contained use" procedure. Dossier submitted on 23/07/2019. | A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and | Themis Bioscience GmbH | Humans | Recombinant measles virus vaccine strain (Schwarz strain) expressing the envelop glycoprotein GPC and the nucleoprotein NP with a mutated exonuclease domein (GCP-rNP) from Lassavirus |
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2015. | A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) | Catapult Cell Therapy | Humans | Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR) |
B/BE/12/BVW1 | A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy | TheraVectys | Humans | genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins |
Only notified under the "contained use" procedure. Dossier submitted on 23/04/2012. | Randomized Phase III of haploidentical HCT with or without an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukemia | Molmed S.p.A. | Humans | -Thymidine Kinase (HSV-Tk) - selection marker |
B/BE/09/BVW1 | A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 | N.V. Roche S.A. | Humans | E6 and E7 genes of the HPV16 virus and gene of the human Interleukin-2 (hIL2) |
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) |