Search the database for deliberate release of GM medicinal products

Displaying 1 - 11 of 11

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
Only notified under the "contained use" procedure. Dossier submitted on 18/11/2021.	A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Safety and Immunogenicity of an Ad26,RSV,preF-based Vaccine in Adults Aged 18 to 59 years, Including Those at High-risk for severe RSV	Janssen Vaccines & Prevention B.V.	Humans	Replication deficient Adenovirus serotype 26 containing a deoxyribonucleic acid (DNA) transgene that encodes the pre-fusion conformation-stabilized F protein (pre-F) derived from the RSV A2 strain
J&JBE-018_004	A randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26COVS1 in adults aged 18 to 65 years, inclusive and adults aged 65 years and older.	Janssen Vaccines & Prevention B.V.	Humans	Recombinant Adenoviral vector serotype 26 expressing the spike glycoprotein 1 from SARS-CoV2
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 05/10/2018.	Open-label, Single-arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults	Janssen Vaccines & Prevention B.V.	Humans	Replication deficient Adenovirus serotype 26 containing a deoxyribonucleic acid (DNA) transgene that encodes the pre-fusion conformation-stabilized F protein (pre-F) derived from the RSV A2 strain
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 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/12/BVW2	Clinical trial evaluating the safety and efficacy of intracoronary administration of MYDICAR (AAV1/SERCA2a) in subjects with heart failure	Celladon	Humans	Human SERCA2a:CA++ pump involved in the regulation of heart contraction/relaxation cycle
Only notified under the "contained use" procedure. Dossier submitted on 13/10/2000.	A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination wi	Glaxo Wellcome	Humans	vCP-1452
B/BE/98/B6	Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers	Schering Plough NV/SA	Humans	wild-type p53 tumor suppressor gene
Only notified under the "contained use" procedure. Dossier submitted on 18/08/1997.	A phase II gene therapy study in patients with non-small cell lung cancer using SCH58500 (rAd/p53) in combination with chemotherapy for multiple cycles	Schering Plough NV/SA	Humans	Wild-type p53
Only notified under the "contained use" procedure. Dossier submitted on 21/10/1996.	A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection	Schering Plough NV/SA	Humans	Wild-type p53