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
B/BE/21/BVW4	An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients with Stage IV Colorectal Cancer	AMAL Therpeutics	Humans	VSV-GP128 is a recombinant live-attenuated Vesicular Stomatitis Virus (VSV), modified to minimize the potential of neurotoxicity for humans and skin disease in animals, and engineered to contain cancer antigens, which help it induce an immune response against colorectal tumour cells.
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
COVID-19-101	A randomized, placebo-controlled trial, to evaluate the safety and immunogenicity of the COVID-19 vaccine, a measles vector-based vaccine candidate against COVID-19 in healthy volunteers consisting of an unblinded dose escalation and a blinded treatment p	Institut Pasteur & Themis Bioscience GmbH	Humans	Recombinant measles virus vaccine strain (Schwarz strain) expressing the Spike glycoprotein 1 from SARS-CoV2
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
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2018.	A Phase I/II study of the safety and efficacy of a single dose of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells in subjects with severe sickle disease	CRISPR Therapeutic AG	Humans	Modified cells expressing Hemoglobin F (HbF)
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
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
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).