Search the database for deliberate release of GM medicinal products

Displaying 1 - 10 of 10

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/22/BVW4	A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors	Nouscom Srl	Humans	The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the FSP neoantigens; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the same neoantigens.
B/BE/20/BVW5	Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Nous-PEV, with pembrolizumab, in Patients with Unresectable Stage III / IV Cutaneous Melanoma and with Stage IV NSCLC	Nouscom Srl	Humans	The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the PEV neoantigens gene; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the neoantigens gene.
B/BE/20/BVW2	A first-in human, Phase 1b/2, study to evaluate the safety, tolerability and immunogenicity of HPV viral vectored vaccines in women with low-grade HPV-related cervical lesions	Vaccitech Limited	Humans	The study involves two GMOs. ChAdOx1-HPV is a recombinant replication-incompetent chimpanzee-derived adenovirus (ChAdY25) viral vector. MVA-HPV is a modified vaccinia virus Ankara vector (MVA). Both vectors encode a fusion of sequences derived from HPV.
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
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
FLU10	Clinical trial (phase II) to evaluate the efficacy of MVANP+M1 in a human H3N2 influenza challenge model.	Vaccitech Limited	Humans	Vaccinia virus Ankara strain expressing nucleoprotein (NP) and Matrix protein (M1) from influenza A H3N2 virus
B/BE/18/BVW6	Global study of a recombinant adeno-associated virus designed to address the monogenic root cause of Spinal Muscular Atrophy	AveXis	Humans	Recombinant adeno-associated virus serotype 9 (AAV9) containing the cDNA of the human SMN (Survival Motor Neuron) gene
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 13/10/2000.	A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination wi	Glaxo Wellcome	Humans	vCP-1452
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)