EMA granted a PRIME Designation to allogenic off-the shelf CAR-T (WU-CART-007) for the treatment of Relapsed/Refractory T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL)
The EMA has granted a PRIME Designation to Wugen's WU-CART-007 for the treatment of Relapsed/Refractory T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).
The application for PRIME designation was based on data from Non-clinical and Clinical exploratory data. The PRIMe Designation was granted on 25 April 2024.
As a reminder, WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies, and has received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the U.S. FDA for the treatment of r/r T-ALL/LBL.
Reference link: List of medicines currrently in PRIME - April 2024