Search the database for deliberate release of GM medicinal products
| 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 |
| CP0201-NHL |
A Phase I/II, multicenter study, evaluating the feasibility, safety, and efficacy of point-of-care manufactured 19CP02 in subjects with relapsed/refractory B-cell non-Hodglin lymphoma |
CellPoint B.V. |
Humans |
CD19-CAR |
| B/BE/18/BVW3 |
A phase 2 study to assess the safety and efficacy of GM Lactococcus lactis for the attenuation of oral mucositis in subjects with cancers of the head and neck |
Oragenics, Inc. |
Humans |
Biologically contained strain of Lactococcus lactis, genetically modified to secrete human Trefoil Factor 1 (hTFF1). |
| 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 |
