Search the database for deliberate release of GM medicinal products
| EU record number |
Title |
Company / Sponsor |
Treated organism |
Genetic modification |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung |
Janssen-Cilag International NV |
Humans |
Genetically modified, live attenuated Listeria monocytogenes (Lm ΔactA/ΔinlB) |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
Efficacy and safety of bilateral intravitreal injection of GS010: a randomized, double-masked, placebo-controlled trial in subjects affected with G11778A ND4 leber hereditary optic neuropathy for up to one year. |
GenSight Biologics |
Humans |
human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4) |
| 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 |
| B/BE/12/BVW1 |
A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy |
TheraVectys |
Humans |
genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects |
ActoGenix |
Humans |
Human Trefoil Factor 1 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
Randomized Phase III of haploidentical HCT with or without an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukemia |
Molmed S.p.A. |
Humans |
-Thymidine Kinase (HSV-Tk)
- selection marker |
