1. adaptimmune llc
  2. sangamo therapeutics
  3. biomarin pharmaceutical inc.
  4. uniqure biopharma b.v.
  5. t-knife gmbh
  6. genetic therapy, inc., sandoz pharma, ltd
  7. merck sharp & dohme corp
  8. vion pharmaceuticals, inc.
  9. institut de recherches internationales servier
  10. Search the database for deliberate release of GM medicinal products

Search the database for deliberate release of GM medicinal products

Displaying 1 - 8 of 8
EU record number Title Company / Sponsor Treated organism Genetic modification
Only notified under the "contained use" procedure. Dossier submitted on 28/10/2021. A Phase I/II, First-in-human, open-label, accelerated-titration, two-part clinical trial of TK-8001 in patients with HLA-A*02:01 genotype and advanced-stage/metastatic, MAGE-A1 + solid tumors that either have no further approved therapeutic alternative(s) T-Knife GmbH Humans chimere MAGE-A1 TCRs
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
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019. A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant Sangamo therapeutics Humans chimeric antigen receptor specific to the donor HLA A*2
ADP-0055-001 A phase I, ascending dose, to evaluate safety and efficacy of ADP A2M4CD8 in HLA-A2+ patients with MAGE-A4 psoitives tumors Adaptimmune LLC Humans MAGE-A4 specific T cell receptor (TCR) with a CD8α co-receptor
B/BE/18/BVW7 Phase III trial investigating a AAV vector containing a variant of human factor IX gene administered to adult subjects with severe or moderately-severe hemophilia B uniQure biopharma B.V. Humans Recombinant adeno associated viral vector containing the wild type modified to express the Padua derivative of human coagulation factor IX cDNA
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)
Only notified under the "contained use" procedure. Dossier submitted on 25/06/1999. A phase I feasibility trial of a live, genetically modified Salmonella typhimurium bacillus (VNP20009) for the treatment of cancer by intra-tumoral injection Vion Pharmaceuticals, Inc. Humans Not relevant
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)