T-CURX, a leading European CAR-T biotechnology company, has secured its first clinical trial approval from Swiss regulatory authority Swissmedic for TCX-001, the company’s lead non-viral CAR-T therapy targeting Siglec-6. 

The approval paves the way for the initiation of a first-in-human Phase 1 clinical study at University Hospital Zürich, which will serve as the first trial site for patients with relapsed or refractory (r/r) Acute Myeloid Leukemia (AML) and Chronic Lymphocytic Leukemia (CLL), including individuals who are not candidates for stem cell transplantation.

The company also plans to submit a complementary Clinical Trials Information System (CTIS) application to the European Medicines Agency (EMA) to expand the study to four additional sites in Germany under the leadership of University Hospital Würzburg. 

The trial is expected to enroll up to 23 adult patients with r/r AML or CLL and aims to establish the recommended Phase 2 dose. Primary study endpoints include safety, tolerability, and dose-limiting toxicities, while secondary endpoints will evaluate overall response rate, duration of response, and CAR-T cell expansion and persistence.

Ulf Grawunder, Chief Executive Officer and co-founder of T-CURX, said the approval marks a significant step forward for the company’s lead CAR-T program and validates its innovative non-viral CAR-T platform. 

Michael Hudecek, Chief Medical Officer and co-founder of T-CURX, highlighted that TCX-001 is built on the company’s non-viral Sleeping Beauty platform, which has already demonstrated clinical feasibility in the academic CAR-T studies CARAMBA-1 and LION-1 conducted at University Hospital Würzburg.