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/24/BVW4	A phase 3 multinational, open-label, systemic gene delivery study to evaluate the safety and efficacy of SRP-9003 in subjects with limb girdle muscular dystrophy 2E/R4	Sarepta Therapeutics	Humans	Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the full-length sarcoglycan-beta (SGCB) gene
B/BE/23/BVW2	A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887(AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular De	Janssen-Cilag International NV	Humans	Non-replicating recombinant vector derived from adeno-associated virus AAV2 carrying the soluble human CD59 gene
B/BE/22/BVW6	A phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of SRP-9001 in Non-Ambulatory and Ambulatory Subjects With Duchenne Muscular Dystrophy (ENVISION)	Sarepta Therapeutics	Humans	Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the human micro-dystrophin (hMicro-Dys) gene
B/BE/21/BVW7	Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors	SCS Boehringer Ingelheim Comm.V	Humans	BI 1831169 is a recombinant live-attenuated Vesicular Stomatitis Virus (rVSV), modified to replace the VSV-G glycoprotein with the Lymphocytic Choriomeningitis Virus glycoprotein in order to minimize the potential of neurotoxicity for humans and skin disease in animals.
B/BE/21/BVW5	A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK)	Sarepta Therapeutics	Humans	Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the human micro-dystrophin (hMicro-Dys) gene
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019.	A randomized Double-blind, Placebo-controlled First-in-Human, Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Oth	Janssen-Cilag International NV	Humans	Recombinant Adenovirus serotype 26 and MVA Bavarian Nordic strain
68284528MMY2003	A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with R	Janssen-Cilag International NV	Humans	Autologous T cells expressing BCMA (B-cell maturation antigen)-CAR
68284528MMY2001	A Phase 1b-2, open-label study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) therapy directed against BCMA in subjets with relapsed or refractory multiple myeloma. Protocol 68284528MMY2001	Janssen-Cilag International NV	Humans	B-cell maturation antigen (BCMA)-chimeric antigen receptor
Only notified under the "contained use" procedure. Dossier submitted on 29/03/2018.	An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung	Janssen-Cilag International NV	Humans	Genetically modified, live attenuated Listeria monocytogenes (Lm ΔactA/ΔinlB)
B/BE/11/BVW2	Clinical Study BNIT-PRV-301 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer	BN-Immunotherapeutics	Humans	Human gene coding for the prostate-specific antigen (PSA) and genes encoding 3 human immunological costimulatory molecules
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)
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)