Search the database for deliberate release of GM medicinal products
Displaying 1 - 14 of 14
| EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
|---|---|---|---|---|
| B/BE/24/BVW5 | Phase 3, open-label, single-arm study to evaluate efficacy and safety of FIX gene transfer with PF-06838435 (rAAV-Spark100-hFIX-R338L) in adult male participants with moderately severe to severe hemophilia B (FIX:C ≤2%) (BeneGene-2) | Pfizer | Humans | Recombinant adeno associated viral vector containing the codon-optimised human factor IX (FIX) minigene (R338L variant) |
| 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| B/BE/20/BVW6 | Dossier withdrawn by the notifier | Pfizer | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV6 serotype, containing a codon-optimised version of the human Factor VIII gene |
| B/BE/20/BVW4 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy | Pfizer | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV9, lacking all AAV viral genes and containing a miniaturized version of the human dystrophin gene |
| B/BE/18/BVW3 | A phase 2 study to assess the safety and efficacy of GM Lactococcus lactis for the attenuation of oral mucositis in subjects with cancers of the head and neck | Oragenics, Inc. | Humans | Biologically contained strain of Lactococcus lactis, genetically modified to secrete human Trefoil Factor 1 (hTFF1). |
| Only notified under the "contained use" procedure. Dossier submitted on 04/05/2018. | Phase IIa clinical trial for the evaluation of a vaccin against influenza virus H3N2 | FluGen Inc. | Humans | recombinant H3N2 influenza virus: 6 intern genes of the replication defective A/Puerto Rico/8/34 (PR8) strain with hemagglutinine and neuraminidase from A/Brismane/10/2007 (H3N2) 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 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) |
| Only notified under the "contained use" procedure. Dossier submitted on 20/08/2015. | A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) | Catapult Cell Therapy | Humans | Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR) |
| B/BE/08/BVW1 | MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants | MedImmune LLC | Humans | Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F). |
| B/BE/01/V6 | Evaluation of efficacy of Salmonella Dublin-Typhimurium vaccine, double gene deleted avirulent live culture in calves. | Pharmacia Animal health | calves | genetic modification of Salmonella enterica by deletion of 2 genes (ssaC and ssaT) |
| B/BE/98/B6 | Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers | Schering Plough NV/SA | Humans | wild-type p53 tumor suppressor gene |
| Only notified under the "contained use" procedure. Dossier submitted on 18/08/1997. | A phase II gene therapy study in patients with non-small cell lung cancer using SCH58500 (rAd/p53) in combination with chemotherapy for multiple cycles | Schering Plough NV/SA | Humans | Wild-type p53 |
| Only notified under the "contained use" procedure. Dossier submitted on 21/10/1996. | A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection | Schering Plough NV/SA | Humans | Wild-type p53 |