38
Participants
Start Date
July 31, 2026
Primary Completion Date
December 31, 2028
Study Completion Date
December 31, 2028
CD318-CAR-T cells
Autologous T cells collected by leukapheresis, genetically modified using a GMP-manufactured lentiviral vector encoding a fully human CD318-specific chimeric antigen receptor (CAR), and expanded on the CliniMACS Prodigy system. After lymphodepleting chemotherapy (fludarabine/cyclophosphamide), participants receive (Phase I) a single CAR-T infusion per BOIN dose-escalation to determine MTD/RP2D; (Phase IIa) an expansion at RP2D with a predefined dual-dosing schedule (two infusions) separated by a protocol-defined interval.
University Hospital Freiburg
OTHER
Technical University of Munich
OTHER
National Center for Tumor Diseases, Heidelberg
OTHER
Wuerzburg University Hospital
OTHER
Berlin Institute of Health
OTHER
Miltenyi Biotec B.V. & Co. KG
INDUSTRY
University Hospital Tuebingen
OTHER