Search the database for deliberate release of GM medicinal products
| EU record number |
Title |
Company / Sponsor |
Treated organism |
Genetic modification |
| B/BE/26/BVW4 |
A Phase 1/2/3, Open-Label, Dose Escalation, Dose Expansion, and Randomized, Controlled Study to Evaluate the Safety and Efficacy of ATSN-201 Gene Therapy in Subjects with RS1-Associated X-linked Retinoschisis (LIGHTHOUSE) |
ASTENA Therapeutics |
Humans |
Non-replicating recombinant vector derived from adeno-associated virus AAV44.9 carrying functional copies of the human retinoschisin (hRS1) gene. |
| B/BE/26/BVW3 |
A phase I/II/III study with a dose determination part followed by an efficacy and safety evaluation, quadruple blind placebo-controlled part and then by a long-term safety follow up part, in ambulant boys with Duchenne Muscular Dystrophy |
GENETHON |
Humans |
Non-replicating recombinant vector derived from adeno-associated virus AAV, lacking all AAV viral genes and carrying the human dystrophin (hMD1) gene |
| B/BE/26/BVW2 |
An Open-label, Multicenter, Two Part, Ascending Dose Followed by a Controlled Trial to Assess the Safety and Efficacy of a Subretinal Administration of AAVB-039 in Participants with Stargardt Disease (STGD1) (CELESTE) |
AAVantgarde Bio UK Ltd. |
Humans |
Non-replicating recombinant dual vector derived from adeno-associated virus AAV8 carrying functional copies of the ABCA4 gene. |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD-19-targeted NEXT-T CAR-T Cells, Versus Standard of Care in Participants with Active Systemic Sclerosis (Breakfree-SSc) |
Celgene |
Humans |
CD19 CAR |
| B/BE/07/BVW3 |
A multi-centre phase I study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX102-3697 HBV pDNA/INX102-0557 HBV MVA in healthy volunteers and HBeAg+ chronic hepatitis patients |
GENimmune N.V. |
Humans |
Hepatitis B virus polyepitope gene |
| B/BE/07/BVW1 |
Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis |
ActoGeniX N.V. |
Humans |
Gene coding for the human interleukin-10 (hIL-10) |
| B/BE/99/VW8 |
Development of a combined live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a sucutaneous administration of a recombinant canarypoxvirus expressing FELV genes. |
Merial |
cats |
env and gag genes of the type A virus of feline leukemia (FELV) |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase I feasibility trial of a live, genetically modified Salmonella typhimurium bacillus (VNP20009) for the treatment of cancer by intra-tumoral injection |
Vion Pharmaceuticals, Inc. |
Humans |
Not relevant |
