Search the database for deliberate release of GM medicinal products

Displaying 1 - 3 of 3

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/25/BVW5	GenePHIT: A study to learn more about how well a new gene therapy (AB-1002) works and its safety in participants with congestive heart failure	Asklepios BioPharmaceutical (AskBio)	Humans	Non-replicating recombinant vector derived from adeno-associated virus AAV2i8 carrying the transgene encoding for the human activated Inhibitor-1c ( I-1c)
Only notified under the "contained use" procedure. Dossier submitted on 10 September 2025 .	A phase 2, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD-19-Targeted NEXT-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Active Systemic Lupus Erythematosus (SLE) (Including Lupus Nephritis) with Inadequate Response to Glucoc	Celgene	Humans	CD19 CAR
Only notified under the "contained use" procedure. Dossier submitted on 20 March 2025 .	A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants with Relapsed or Refractory and Lenalidomide-refractory Multiple My	Celgene	Humans	GPRC5D CAR