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Heidagenlecleucel (Heidi-cel) is an autologous, third-generation chimeric antigen receptor (CAR) T-cell therapy targeting CD19. Developed by Heidelberg University Hospital, it is designed for the treatment of CD19-positive hematologic malignancies, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), and non-Hodgkin's lymphoma (NHL). Unlike standard second-generation CAR-T therapies, heidagenlecleucel incorporates both CD28 and 4-1BB (CD137) costimulatory domains alongside the CD3-zeta signaling domain to enhance T-cell activation, expansion, and persistence. In Germany, the Paul-Ehrlich-Institut (PEI) granted a hospital exemption (Krankenhausausnahme) for heidagenlecleucel, allowing for its in-house manufacturing and clinical administration.
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