Wugen's Investigational Allogeneic Anti-CD7 CAR-T Therapy Sofi-cel Receives FDA Breakthrough Therapy Designation for Relapsed/Refractory T-ALL/LBL

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On January 21, 2026, Wugen, Inc., a clinical-stage biotechnology company, announced that its allogeneic, off-the-shelf cell therapy for the treatment of hematologic malignancies has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA).

Sofi-cel is a potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy currently under investigation. It is being evaluated in a pivotal trial (T-RRex) for patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma (T-ALL/LBL). The Breakthrough Therapy Designation aims to expedite the development and review of drugs intended for serious or life-threatening conditions with evidence of substantial clinical improvement. Sofi-cel has previously received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. FDA, as well as Priority Medicines (PRIME) designation from the European Union for its treatment.Treatment of R/R T-ALL/T-LBL.

Regulatory agencies granted Wugen this designation after reviewing relevant data, including results from the global Phase 1/2 clinical trial evaluating Sofi-cel for the treatment of relapsed/refractory T-ALL/LBL patients. The pivotal Phase 2 T-RRex study is a single-arm trial designed to assess the safety and efficacy of Sofi-cel in patients with relapsed/refractory T-ALL/LBL.

"The FDA's Breakthrough Therapy Designation highlights the promising clinical data we have generated and the potential of Sofi-cel to bring meaningful change to patients with relapsed or refractory T-ALL/LBL. This recognition enables us to work closely with the FDA to accelerate the development process and ultimately bring this innovative therapy to patients as soon as possible," said Dr. Cherry Thomas, Chief Medical Officer of Wugen.

Reference: Company Announcement