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/BVW2 | Phase I study to assess safety, tolerability and immunogenicity of the hRVFV-4s vaccine in healthy subjects | Wageningen Bioveterinary Research (Larissa Consortium) | Humans | hRVFV-4s is a four segments human Rift Valley fever virus vaccine, which derives from a natural clone (Clone 13) that lacks 69% of the gene NSs, a major virulence determinant of the virus. The hRVFV-4s vaccine is further attenuated by splitting the M genome segment into two M-type segments. |
MB-CART2019.1 | A phase I/II safety, dose finding and feasibility trial of MB-CART2019.1 in patients with relapsed or resistant B-NHL | Miltenyi Biotech GmbH | Humans | CD19 and CD20 chimeric antigen receptor |
EBOVEU001 | A phase IIa partial blind, placebo-controlled clinical trial to evaluate the safety and immunogenicity of the Ad5-EBOV in healthy adults aged between 18 and 60 years in Belgium. | Bejing Institute of Biotechnology, CanSino Biologics Inc, | Humans | Recombinant Adenoviral vector serotype 5 expressing the envelop glycoprotein from Ebola virus (Zaïre-Makona) |
B/BE/18/BVW5 | A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus | Intrexon T1D Partners, LLC | Humans | Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin |
Only notified under the "contained use" procedure. Dossier submitted on 21/02/2018. | Efficacy and safety of bilateral intravitreal injection of GS010: a randomized, double-masked, placebo-controlled trial in subjects affected with G11778A ND4 leber hereditary optic neuropathy for up to one year. | GenSight Biologics | Humans | human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4) |
Only notified under the "contained use" procedure. Dossier submitted on 01/02/2005. | A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma | Ark Therapeutics Ltd | Humans | Thymidine Kinase (HSV-TK1) |
Only notified under the "contained use" procedure. Dossier submitted on 11/07/2002. | A European and Canadian multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina | Schering N.V./S.A. | Humans | human FGF-4 |
Only notified under the "contained use" procedure. Dossier submitted on 09/06/1998. | A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous | Rhone-Poulenc Rorer | Humans | Wild-type p53 |