Search the database for deliberate release of GM medicinal products
| EU record number |
Title |
Company / Sponsor |
Treated organism |
Genetic modification |
| 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 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
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 (CLL) or Small Lymphocytic Lymphoma (SLL) (CP0101-CLL) – Eup |
CellPoint B.V. (a Galapagos company) |
Humans |
CD19 CAR |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
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. (a Galapagos company) |
Humans |
BCMA CAR |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of |
Genetic therapy, Inc., Sandoz Pharma, Ltd |
Humans |
Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR) |
