EMA grants PRIME designation to anti-CD30 CAR-T cell therapy for the treatment of patients with R/R cHL

On January 18, 2021, it was announced that the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation to CD30-targeting chimeric antigen receptor (CAR)-T cells, TT11 CD30.CAR-T cells, for the treatment of relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL).¹

The decision was based on results of two parallel phase I/II trials (NCT02690545 and NCT02917083) investigating the efficacy and safety of TT11 CD30.CAR-T cells, which were published in the Journal of Clinical Oncology. These results were previously reported on the Lymphoma Hub and showed that ~60% of patients treated at the highest dose level had a complete disappearance of tumor, with no serious toxicities.¹

TT11 CD30.CAR-T cell therapy²

• Targets CD30, a member of the tumor necrosis factor receptor superfamily, that is expressed on cancerous cells in Hodgkin lymphoma and various non-Hodgkin lymphomas, but only in a small subset of activated T and B cells, which reduces the likelihood of off-target-related adverse effects.
• Has demonstrated encouraging efficacy results and a favorable toxicity profile in heavily pretreated patients with Hodgkin lymphoma.
• Previously granted Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration (FDA).
• Also being investigated in a phase I trial (NCT04526834) for patients with R/R CD30-positive non-Hodgkin lymphoma.