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/01/B7 |
Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer" |
Transgene S.A. |
Humans |
sequences coding for the human MUC-1 antigen and IL-2 |
| B/BE/01/V6 |
Evaluation of efficacy of Salmonella Dublin-Typhimurium vaccine, double gene deleted avirulent live culture in calves. |
Pharmacia Animal health |
calves |
genetic modification of Salmonella enterica by deletion of 2 genes (ssaC and ssaT) |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase III, multi-center, open-label, randomized study to compare the effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of |
Introgen Therapeutics, Inc. |
Humans |
Wild-type p53 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase III, multi-center, open-label, randomized study to compare the overall survival and safety of bi-weekly intratumoral administration of INGN 201 versus weekly methotrewate in 240 patients with refractory squamous cell carcinoma of the head and neck |
Introgen Therapeutics, Inc. |
Humans |
Wild-type p53 |
