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. |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies. |
Novartis Pharma Services AG |
Humans |
CD19 CAR |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
Phase II study evaluating rapcabtagene autoleucel in participants with diffuse cutaneous systemic sclerosis (dcSSc) |
Novartis Pharma Services AG |
Humans |
CD19 CAR |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia |
Novartis Pharma Services AG |
Humans |
Chimeric antigen receptor against CD19 |
| 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 |
