The US Food and Drug Administration granted breakthrough therapy designation to chimeric antigen receptor T-cell therapy soficabtagene geleucel (WU-CART-007) for the therapy of T-cell malignancies. Sofi-cell is currently being evaluated in the pivotal phase 2 T-RRex trial for patients with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
The T-RRex trial is a single-arm, multicenter, open label study in patients with relapsed or refractory T-ALL/LBL and T-ALL/LBL in remission but remaining measurable residual disease positive.
Sofi-cel, an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy, has previously received regenerative medicine advanced therapy, fast track, orphan drug, and rare pediatric disease designations from the FDA and Priority Medicines Scheme designation in the European Union for the treatment of both diseases.
