Search the database for deliberate release of GM medicinal products

Displaying 1 - 12 of 12

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/21/BVW8	Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene	Meira GTx UK II Limited	Humans	Non-replicating recombinant vector derived from adeno-associated virus AAV 5 carrying the human RPGR gene
Only notified under the "contained use" procedure. Dossier submitted on 03/05/2021.	Administration of genetically engineered T cells (KTE-X19) in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma	Kite Pharma	Humans	CD19-CAR
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 25/04/2018.	A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)	Kite Pharma	Humans	Chimeric antigen receptor against CD19
B/BE/12/BVW2	Clinical trial evaluating the safety and efficacy of intracoronary administration of MYDICAR (AAV1/SERCA2a) in subjects with heart failure	Celladon	Humans	Human SERCA2a:CA++ pump involved in the regulation of heart contraction/relaxation cycle
B/BE/04/BV1	Evaluation of the safety of Feline Herpes Virus, bivalent deleted live vaccine, administered as intranasal vaccine to cats	Pfizer, Animal Health Group	cats	gene for the env glycoprotein or gene for the gag protein of the Feline immunodeficiency virus (FIV)
B/BE/00/V15	Development of a combined vaccine against equine influenza and tetanus. Experiment outside containment (clinical trial) for the study of the safety and efficacy of an intramuscular administration of recombinant canarypoxvirus expressing equine influenza v	Merial	Horses	haemagglutinin gene from equine influenza virus A2/Kentucky/94 or equine influenza virus A2/Newmarket/2/93
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
B/BE/99/VW8	Development of a combined live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a sucutaneous administration of a recombinant canarypoxvirus expressing FELV genes.	Merial	cats	env and gag genes of the type A virus of feline leukemia (FELV)
B/BE/97/VW9	Development of a live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a subcutaneous administration of a recombinant canarypoxvirus expressing FELV genes.	Merial	cats	env and gag genes of the type A virus of feline leukemia (FELV)
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)