Search the database for deliberate release of GM medicinal products

Displaying 1 - 9 of 9
EU record number Title Company / Sponsor Treated organism Genetic modification
Only notified under the "contained use" procedure. Dossier submitted on 25/07/2022. A Phase I/II study to evaluate the feasibility, safety and preliminary efficacy of point-of-care manufactured anti-CD19 CAR T in subjects with relapsed or refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (SLL) CellPoint B.V. Humans CD19 CAR
Only notified under the "contained use" procedure. Dossier submitted on 07/06/2022. A phase I/II open label, multicenter study evaluating the feasibility, safety and efficacy of point-of-care manufactured anti-BCMA CAR T cells (BCMACP03) in subjects with relapsed/refractory Multiple Myeloma (r/r MM) (Papilio-1) CellPoint B.V. Humans BCMA CAR
B/BE/21/BVW3 Phase I/II study to evaluate the safety and effects on Progranulin levels of PR006 in patients with Fronto-Temporal Dementia with Progranulin mutations (FTD-GRN). Prevail Therapeutics Humans The study involves a replication-incompetent adeno-associated virus, AAV9, lacking all AAV viral genes and encoding for the human Progranulin (GRN) gene
CP0201-NHL A Phase I/II, multicenter study, evaluating the feasibility, safety, and efficacy of point-of-care manufactured 19CP02 in subjects with relapsed/refractory B-cell non-Hodglin lymphoma CellPoint B.V. Humans CD19-CAR
B/BE/19/BVW4 Importation of doses of V920 for Emergency Use Merck Sharp & Dohme B.V. Humans Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene encoding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein (GP).
B/BE/08/BVW1 MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants MedImmune LLC Humans Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F).
B/BE/07/BVW3 A multi-centre phase I study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX102-3697 HBV pDNA/INX102-0557 HBV MVA in healthy volunteers and HBeAg+ chronic hepatitis patients GENimmune N.V. Humans Hepatitis B virus polyepitope gene
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 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