The U.S. Food and Drug Administration (FDA) has officially lifted the clinical hold on the Investigational New Drug (IND) application for tablecleucel (Tab-Cel; Ebvallo), an off-the-shelf allogeneic T-cell therapy designed to treat Epstein-Barr Virus-positive post-transplant lymphoproliferative disorder (EBV+ PTLD).
The clinical hold was initially imposed in January 2025 due to issues with good manufacturing practices (GMP) at a third-party production facility. However, following the submission of supplemental data from Atara Biotherapeutics, the company behind Tab-Cel, the FDA has now cleared the way for clinical trials to resume.
Tab-Cel is being investigated through multiple studies, including the phase 3 ALLELE study and the phase 2 EBVision study, both of which are focused on patients with EBV+ PTLD. These trials will now continue as originally planned, allowing researchers to further evaluate the safety and efficacy of the therapy.
The Tab-Cel therapy has the potential to be a solution for patients with EBV+ PTLD, a serious complication that can arise after organ transplants. If the therapy is ultimately approved, it would become the first FDA-approved treatment for this rare and challenging condition.
The ALLELE phase 3 study has already shown promising results, with an overall response rate of 50.7% among 75 patients treated with Tab-Cel, including a complete response rate of 28%.
