Federal Project Grant Award Summary

The University of Pennsylvania received a $6.84 million Project Grant from the Food and Drug Administration (FDA) under the Food and Drug Administration Research program (CFDA 93.103), awarded September 30, 2025, with an ultimate completion date of August 31, 2029. This grant funds a first-in-human Phase I clinical trial evaluating CD5-deleted anti-CD5 chimeric antigen receptor T-cell (SENZA5 CART5) immunotherapy for relapsed or refractory T-cell non-Hodgkin lymphoma (T-NHL). The primary deliverables include clinical trial data assessing the feasibility, safety, toxicity, and efficacy of this novel CAR-T cell therapy approach, which addresses a significant unmet medical need in treating T-cell lymphomas that are largely refractory to current therapeutic options.

The research builds on the institution's preliminary findings demonstrating that deletion of the CD5 pan-T-cell antigen both prevents CAR-T cell fratricide and enhances T-cell effector function through improved CAR signaling. The trial will also evaluate whether CD5-knockout untransduced T cells present in the product formulation can provide short-term immune protection in cases of therapy-related toxicity. Led by a multidisciplinary team with complementary oncology, immunology, and translational medicine expertise, this FDA-funded initiative represents a translational advance in CAR-T cell immunotherapy targeting a previously intractable malignancy.