Search the database for deliberate release of GM medicinal products
Displaying 1 - 4 of 4
|EU record number
|Company / Sponsor
|Only notified under the "contained use" procedure. Dossier submitted on 03/05/2021.
|Administration of genetically engineered T cells (KTE-X19) in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
|A phase 2 vaccine study in healthy adults and adolescents to evaluate the safety and immunogenicity of two oral polio type 2 vaccine candidates
|University of Antwerp
|The nOPV2 candidate strains include different combinations of 5 distinct modified regions of the Sabin-2 genome, including changes to the RNA sequence in the 5’ untranslated region of polio genome (5’ UTR), the capsid protein coding region (P1), the non-structural protein 2C, and the polymerase 3D. Of these modifications, only the changes to polymerase 3D result in a change in the amino acid sequence. The rest of the modifications aim to stabilize the genetic sequence against reversion in either the 5’ UTR or capsid regions.
|Only notified under the "contained use" procedure. Dossier submitted on 20/08/2018.
|A Phase I/II study of the safety and efficacy of a single dose of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells in subjects with severe sickle disease
|CRISPR Therapeutic AG
|Modified cells expressing Hemoglobin F (HbF)
|Only notified under the "contained use" procedure. Dossier submitted on 25/04/2018.
|A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)
|Chimeric antigen receptor against CD19