Search the database for deliberate release of GM medicinal products

Displaying 1 - 7 of 7

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
Only notified under the "contained use" procedure. Dossier submitted on 25 July, 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 (CLL) or Small Lymphocytic Lymphoma (SLL) (CP0101-CLL) – Eup	CellPoint B.V. (a Galapagos company)	Humans	CD19 CAR
Only notified under the "contained use" procedure. Dossier submitted on 7 June, 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. (a Galapagos company)	Humans	BCMA CAR
B/BE/21/BVW9	Dossier withdrawn by the notifier	ActoGenix	Humans	V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30)
Only notified under the "contained use" procedure. Dossier submitted on 18 November, 2021 .	A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Safety and Immunogenicity of an Ad26,RSV,preF-based Vaccine in Adults Aged 18 to 59 years, Including Those at High-risk for severe RSV	Janssen Vaccines & Prevention B.V.	Humans	Replication deficient Adenovirus serotype 26 containing a deoxyribonucleic acid (DNA) transgene that encodes the pre-fusion conformation-stabilized F protein (pre-F) derived from the RSV A2 strain
J&JBE-018_004	A randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26COVS1 in adults aged 18 to 65 years, inclusive and adults aged 65 years and older.	Janssen Vaccines & Prevention B.V.	Humans	Recombinant Adenoviral vector serotype 26 expressing the spike glycoprotein 1 from SARS-CoV2
Only notified under the "contained use" procedure. Dossier submitted on 7 April, 2014 .	A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects	ActoGenix	Humans	gene expressing certolizumab
Only notified under the "contained use" procedure. Dossier submitted on 8 May, 2012 .	A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects	ActoGenix	Humans	Human Trefoil Factor 1