Search the database for deliberate release of GM medicinal products
Displaying 1 - 15 of 15
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
---|---|---|---|---|
Only notified under the "contained use" procedure. Dossier submitted on 25/07/2022. | A Phase I/II study to evaluate the feasibility, safety and preliminary efficacy of point-of-care manufactured anti-CD19 CAR T in subjects with relapsed or refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (SLL) | CellPoint B.V. | Humans | CD19 CAR |
Only notified under the "contained use" procedure. Dossier submitted on 07/06/2022. | A phase I/II open label, multicenter study evaluating the feasibility, safety and efficacy of point-of-care manufactured anti-BCMA CAR T cells (BCMACP03) in subjects with relapsed/refractory Multiple Myeloma (r/r MM) (Papilio-1) | CellPoint B.V. | Humans | BCMA CAR |
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 |
CP0201-NHL | A Phase I/II, multicenter study, evaluating the feasibility, safety, and efficacy of point-of-care manufactured 19CP02 in subjects with relapsed/refractory B-cell non-Hodglin lymphoma | CellPoint B.V. | Humans | CD19-CAR |
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 |
Only notified under the "contained use" procedure. Dossier submitted on 18/02/2020. | A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults | Themis Bioscience GmbH | Humans | Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV |
B/BE/19/BVW4 | Importation of doses of V920 for Emergency Use | Merck Sharp & Dohme B.V. | Humans | Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene encoding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein (GP). |
Only notified under the "contained use" procedure. Dossier submitted on 23/07/2019. | A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and | Themis Bioscience GmbH | Humans | Recombinant measles virus vaccine strain (Schwarz strain) expressing the envelop glycoprotein GPC and the nucleoprotein NP with a mutated exonuclease domein (GCP-rNP) from Lassavirus |
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 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) |
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 08/07/2010. | An open-label, phase I, dose-escalation and safety study of two intramuscular injections at dose of 2.9 log or 4 log CCID50 of the recombinant HIV I clade B measles vaccine vector in healthy adults. | Institut Pasteur - Paris | Humans | Gag, Pol, Nef genes of HIV |
B/BE/09/BVW1 | A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 | N.V. Roche S.A. | Humans | E6 and E7 genes of the HPV16 virus and gene of the human Interleukin-2 (hIL2) |
Only notified under the "contained use" procedure. Dossier submitted on 10/06/2003. | A phase 1 randomized, placebo-controlled, double-blind, dose escalation trial to evaluate the safety and immunogenicity of tgAAC09, a gag-PR-DRT AAV HIV vaccine | International AIDS Vaccine Initiative (IAVI) | Humans | genes for the gag, protease and part of the reverse transcriptase proteins of HIV-1 |