Search the database for deliberate release of GM medicinal products
Displaying 1 - 5 of 5
| EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
|---|---|---|---|---|
| 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 single-arm, open-label, multi-centre, phase I/II study evaluating the safety and clinical activity of QEL-001, an autologous CAR T regulatory cell treatment targeting HLA-A2, in HLA-A2/ A28neg patients that have received an HLA-A2pos liver transplant | Quell Therapeutics Limited | Humans | BCMA CAR; shRNA CD3ζ; tCD34 |
| Only notified under the "contained use" procedure. Dossier submitted on . | Phase IIa clinical trial for the evaluation of a vaccin against influenza virus H3N2 | FluGen Inc. | Humans | recombinant H3N2 influenza virus: 6 intern genes of the replication defective A/Puerto Rico/8/34 (PR8) strain with hemagglutinine and neuraminidase from A/Brismane/10/2007 (H3N2) strain |
| 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 |