A phase 2 registration-directed clinical study of Sofi-cel, an allogeneic CAR-T targeting CD7, in patients with T-ALL/T-LBL

In February 2026, TAP made an equity investment in Allotera (formerly Wugen) to "Support Clinical Development of Sofi-Cel in Relapsed/Refractory T-ALL/T-LBL."

Allotera is a clinical-stage biotechnology company focused on developing next-generation, allogeneic CAR-T cell therapies for cancer. Allotera's proprietary gene-editing platform is designed to overcome key limitations of first-generation cell therapies, enabling scalable, off-the-shelf treatments with biologics-like cost of goods margins.

Soficabtagene Geleucel (Sofi-cel) is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat T-cell cancers. Allotera is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC) genes, thereby preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host disease (GvHD). Sofi-cel is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. Sofi-cel is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-ALL/T-LBL (NCT06514794).

Sofi-cel has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. FDA and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed or refractory T-ALL/T-LBL. RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need.