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
​B/BE/21/BVW4 An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients with Stage IV Colorectal Cancer AMAL Therpeutics Humans VSV-GP128 is a recombinant live-attenuated Vesicular Stomatitis Virus (VSV), modified to minimize the potential of neurotoxicity for humans and skin disease in animals, and engineered to contain cancer antigens, which help it induce an immune response against colorectal tumour cells.
Only notified under the "contained use" procedure. Dossier submitted on 18/11/2021. 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
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
B/BE/20/BVW2 A first-in human, Phase 1b/2, study to evaluate the safety, tolerability and immunogenicity of HPV viral vectored vaccines in women with low-grade HPV-related cervical lesions Vaccitech Limited Humans The study involves two GMOs. ChAdOx1-HPV is a recombinant replication-incompetent chimpanzee-derived adenovirus (ChAdY25) viral vector. MVA-HPV is a modified vaccinia virus Ankara vector (MVA). Both vectors encode a fusion of sequences derived from HPV.
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
B/BE/19/BVW4 Importation of doses of V920 for Emergency Use Merck Sharp & Dohme B.V. Humans Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene encoding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein (GP).
FLU10 Clinical trial (phase II) to evaluate the efficacy of MVANP+M1 in a human H3N2 influenza challenge model. Vaccitech Limited Humans Vaccinia virus Ankara strain expressing nucleoprotein (NP) and Matrix protein (M1) from influenza A H3N2 virus
Only notified under the "contained use" procedure. Dossier submitted on 05/10/2018. Open-label, Single-arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults 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
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 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)