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 |
|---|---|---|---|---|
| B/BE/21/BVW8 | Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene | Meira GTx UK II Limited | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV 5 carrying the human RPGR gene |
| 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 |
| Only notified under the "contained use" procedure. Dossier submitted on 04/10/2018. | A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy | Immune Design | Humans | Replication deficient lentiviral vector encoding NY-ESO-1 cancer testis antigen |
| Only notified under the "contained use" procedure. Dossier submitted on 07/04/2017. | Phase 1 clinical trial evaluation of two genetically modified vaccines against poliovirus | UZ Antwerpen | Humans | Genetic modifications of the nOPV2 vaccine candidates aimed at stabilizing the genetic sequence against reversion compared to the Sabin-2 strain, nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3), nOPV2 candidate 2 (S2/S15domV/CpG40) |
| 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/07/BVW3 | A multi-centre phase I study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX102-3697 HBV pDNA/INX102-0557 HBV MVA in healthy volunteers and HBeAg+ chronic hepatitis patients | GENimmune N.V. | Humans | Hepatitis B virus polyepitope gene |
| 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 |