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/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
Only notified under the "contained use" procedure. Dossier submitted on 03/05/2021.	Administration of genetically engineered T cells (KTE-X19) in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma	Kite Pharma	Humans	CD19-CAR
COVID-19-101	A randomized, placebo-controlled trial, to evaluate the safety and immunogenicity of the COVID-19 vaccine, a measles vector-based vaccine candidate against COVID-19 in healthy volunteers consisting of an unblinded dose escalation and a blinded treatment p	Institut Pasteur & Themis Bioscience GmbH	Humans	Recombinant measles virus vaccine strain (Schwarz strain) expressing the Spike glycoprotein 1 from SARS-CoV2
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
B/BE/18/BVW5	A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus	Intrexon T1D Partners, LLC	Humans	Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin
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 25/04/2018.	A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)	Kite Pharma	Humans	Chimeric antigen receptor against CD19
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)
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2017.	A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukaemia	Institut de Recherches Internationales Servier	Humans	chimeric antigen receptor and suicide-ligand (RQR8)
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
Only notified under the "contained use" procedure. Dossier submitted on 24/10/1996.	Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of	Genetic therapy, Inc., Sandoz Pharma, Ltd	Humans	Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)