Wugen Receives Breakthrough Therapy Designation for WU-CART-007 in Relapsed or Refractory T-ALL/T-LBL
Thursday, January 22, 2026
Wugen has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its investigational CAR-T cell therapy, soficabtagene geleucel (Sofi-cel).
Sofi-cel is a potential first-in-class, off-the-shelf, anti-CD7 allogeneic CAR-T therapy being developed for patients with relapsed or refractory T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma (T-ALL/T-LBL). The designation is intended to speed up the development and review of treatments for serious or life-threatening conditions where early clinical data suggest meaningful improvement over existing options.
The FDA decision was based on data from a global Phase 1/2 clinical study evaluating Sofi-cel in patients with relapsed or refractory T-ALL/T-LBL. The therapy is currently being assessed in the pivotal Phase 2 T-RRex trial, a single-arm study designed to evaluate its safety and effectiveness in this patient population.
Sofi-cel has previously received several regulatory designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug and Rare Pediatric Disease status. It has also been granted Priority Medicines (PRIME) designation in the European Union for the same indication.
Sofi-cel is an allogeneic, donor-derived CAR-T therapy engineered using CRISPR/Cas9 gene-editing technology. The CD7 and TRAC genes are removed to prevent CAR-T cell fratricide and reduce the risk of graft-versus-host disease. Manufacturing from healthy donor T cells also avoids the risk of malignant cell contamination associated with autologous CAR-T therapies.
The pivotal global study of Sofi-cel in relapsed or refractory T-ALL/T-LBL is ongoing. Further details are available on ClinicalTrials.gov under the identifier NCT06514794.
Source: wugen.com
