T-CURX Secures Swissmedic Approval for First-in-Human Trial of Non-Viral CAR-T Therapy TCX-001
核心洞察
T-CURX (搜索) received Swissmedic (搜索) approval to launch a first-in-human Phase 1 trial of TCX-001 (搜索), a non-viral CAR-T therapy targeting Siglec-6 (搜索) in relapsed/refractory AML and CLL.
The dose-escalation study will enroll up to 23 adult patients at University Hospital Zürich, with plans to expand to four additional German sites via a CTIS application to the EMA.
Primary endpoints include safety, tolerability, and dose-limiting toxicities; secondary endpoints assess overall response rate, duration of response, and CAR-T cell expansion and persistence.
T-CURX (搜索), a leading European CAR-T biotechnology company, has received clinical trial approval from Swiss regulatory authority Swissmedic (搜索) for TCX-001 (搜索), its lead non-viral CAR-T therapy targeting Siglec-6 (搜索). The authorization clears the path for a first-in-human Phase 1 study, marking a pivotal milestone for the company's scalable, non-viral CAR-T platform.
The trial will be initiated at University Hospital Zürich, the first study site, and will enroll patients with relapsed or refractory (r/r) Acute Myeloid Leukemia (搜索) (AML) and Chronic Lymphocytic Leukemia (搜索) (CLL), including individuals who are not candidates for stem cell transplantation. T-CURX (搜索) 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.
Trial Design and Endpoints
The Phase 1 dose-escalation study 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 endpoints include safety, tolerability, and dose-limiting toxicities. Secondary endpoints will evaluate overall response rate, duration of response, and CAR-T cell expansion and persistence.
Platform and Clinical Validation
TCX-001 (搜索) is built on T-CURX (搜索)'s proprietary non-viral Sleeping Beauty platform. Michael Hudecek, Chief Medical Officer and co-founder of T-CURX, noted that this platform has already demonstrated clinical feasibility in the academic CAR-T studies CARAMBA-1 and LION-1, both conducted at University Hospital Würzburg.
Ulf Grawunder, Chief Executive Officer and co-founder of T-CURX (搜索), stated that the approval represents a significant step forward for the company's lead CAR-T program and validates its innovative non-viral CAR-T platform. The non-viral approach offers potential advantages in manufacturing scalability and cost compared to traditional viral vector-based CAR-T therapies, though these benefits will require further clinical validation.
Targeting Siglec-6 (搜索) in Hematologic Malignancies
TCX-001 (搜索) targets Siglec-6 (搜索), a cell surface receptor expressed on malignant cells in AML and CLL. By employing a non-viral gene transfer method, the therapy aims to generate CAR-T cells capable of recognizing and eliminating Siglec-6-positive tumor cells while potentially reducing the complexity and expense associated with viral vector manufacturing.