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
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
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
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019.	A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant	Sangamo therapeutics	Humans	chimeric antigen receptor specific to the donor HLA A*2
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
B/BE/18/BVW3	A phase 2 study to assess the safety and efficacy of GM Lactococcus lactis for the attenuation of oral mucositis in subjects with cancers of the head and neck	Oragenics, Inc.	Humans	Biologically contained strain of Lactococcus lactis, genetically modified to secrete human Trefoil Factor 1 (hTFF1).
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)
B/BE/01/V6	Evaluation of efficacy of Salmonella Dublin-Typhimurium vaccine, double gene deleted avirulent live culture in calves.	Pharmacia Animal health	calves	genetic modification of Salmonella enterica by deletion of 2 genes (ssaC and ssaT)