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
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
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
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2018.	A Phase I/II study of the safety and efficacy of a single dose of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells in subjects with severe sickle disease	CRISPR Therapeutic AG	Humans	Modified cells expressing Hemoglobin F (HbF)
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/12/BVW1	A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy	TheraVectys	Humans	genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins