1. transgene s.a
  2. novartis pharma services ag
  3. sandoz pharma, ltd
  4. bejing institute of biotechnology, cansino biologics inc,
  5. hookipa biotech ag
  6. biomarin pharmaceutical inc.
  7. university of antwerp
  8. laboratorios hipra s.a.
  9. Search the database for deliberate release of GM medicinal products

Search the database for deliberate release of GM medicinal products

Displaying 1 - 9 of 9
EU record number Title Company / Sponsor Treated organism Genetic modification
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/19/BVW2 A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Residual FVIII Levels Receiving Prophylactic FVIII BioMarin Pharmaceutical Inc. Humans Recombinant adeno-associated virus serotype 5 (AAV5) containing a gene cassette expressing the human coagulation factor VIII (FVIII) gene
EBOVEU001 A phase IIa partial blind, placebo-controlled clinical trial to evaluate the safety and immunogenicity of the Ad5-EBOV in healthy adults aged between 18 and 60 years in Belgium. Bejing Institute of Biotechnology, CanSino Biologics Inc, Humans Recombinant Adenoviral vector serotype 5 expressing the envelop glycoprotein from Ebola virus (Zaïre-Makona)
B/BE/18/BVW2 A phase 2 vaccine study in healthy adults and adolescents to evaluate the safety and immunogenicity of two oral polio type 2 vaccine candidates University of Antwerp Humans The nOPV2 candidate strains include different combinations of 5 distinct modified regions of the Sabin-2 genome, including changes to the RNA sequence in the 5’ untranslated region of polio genome (5’ UTR), the capsid protein coding region (P1), the non-structural protein 2C, and the polymerase 3D. Of these modifications, only the changes to polymerase 3D result in a change in the amino acid sequence. The rest of the modifications aim to stabilize the genetic sequence against reversion in either the 5’ UTR or capsid regions.
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 22/03/2016. Phase I study to evaluate the safety and immunogenicity of a bivalent recombinant vaccine against human cytomegalovirus (HCMV). Hookipa Biotech AG Humans Two replication-deficient lymphocytic choriomeningitidis virus (rLCMV) vectors, one expressing a truncated gBprotein of HCMV and one expressing the pp65 protein of the human CMV
Only notified under the "contained use" procedure. Dossier submitted on 14/10/2015. A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia Novartis Pharma Services AG Humans Chimeric antigen receptor against CD19
B/BE/11/V3 Evaluation of the safety and efficacy of the vaccine PB-116 in the control of porcine pleuropneumonia caused by Actinobacillus pleuropneumoniae Laboratorios Hipra S.A. pigs no new genes but deletion of a segment of gene A from which depends the haemolytic activity of the pathogen
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)