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/23/BVW3	A Phase I, randomized, double-blind, multi-centre, placebo-controlled, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational vaccine for the prevention of yellow fever (AVX70120), and of AstriVax’ inv	AstriVax NV	Humans	Full genome of the live attenuated yellow fever virus (YFV) strain 17D (YF17D) containing the sequence of the surface glycoprotein from the rabies virus (RabG)
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
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 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 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
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)