Search the database for deliberate release of GM medicinal products
| EU record number |
Title |
Company / Sponsor |
Treated organism |
Genetic modification |
| B/BE/25/BVW3 |
Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) with Severe or Moderately Severe Hemophilia B |
CSL Behring LLC |
Humans |
Recombinant adeno associated viral vector containing the codon-optimised human PADUA factor IX (FIX) 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 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
. |
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 |
