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Committed to Clearly Differentiated
CAR-T Therapies

At T-CURX, we develop next-generation CAR-T therapies with the ambition to deliver durable responses, enhance safety, and make innovative cancer treatments accessible to more patients.

Our clinical-stage lead program, targeting Siglec-6, is designed to address a critical unmet need in Acute Myeloid Leukemia (AML) and Chronic Lymphocytic Leukemia (CLL) by selectively eliminating malignant cells while sparing healthy hematopoietic stem cells. This may eliminate the need for subsequent stem cell transplantation.

Leveraging our clinical experience with ex vivo CAR-T programs, validated target biology, and proprietary non-viral CAR and LNP technologies, we are transitioning toward in vivo CAR-T therapies. Our ambition is to generate CAR-T cells directly within patients via proprietary mRNA and minicircle DNA (mcDNA) payloads and targeted delivery via our LNP technology.

We are advancing a differentiated non-viral in vivo CAR-T pipeline with the potential to deliver durable therapeutic responses, starting with hard-to-treat hematological malignancies such as AML, with subsequent expansion into solid tumor indications.

Our Pipeline

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  • Our clinical lead CAR-T program, TCX-001, targets Siglec-6, which is a highly differentiated target expressed on AML-blasts and leukemic stem cells. In contrast to other AML targets – e.g., CD33 or CD123 – Siglec-6 is not expressed on healthy hematopoietic stem or progenitor cells. This spares the hematopoietic stem cell compartment from being destroyed by CAR-T cells. Based on this unique capability, a Siglec-6-targeting CAR-T therapy could provide an effective standalone treatment option for AML and CLL patients, rather than serving just a bridge-to-transplant therapy.

  • A CAR-T pipeline program being pursued in collaboration with the University Hospital Würzburg – one of Germany’s leading clinical oncology centers – addresses a so-called cross-entity target. A cross-entity target in CAR-T therapy is defined as a target that addresses a tumor associated antigen both in hematological malignancies (blood cancer) as well as solid tumors. The program has received substantial non-dilutive grant funding support.

Clinical Studies

  • The first-in-human Phase 1 clinical trial with the investigational Siglec-6 CAR-T therapy, TCX-001, has been initiated in 2026 for the treatment of r/r AML or CLL patients. The main objective of this study is to evaluate the safety of TCX-001 and to determine the recommended dose for subsequent Phase 2 clinical studies.

  • Primary endpoints are the incidence of dose-limiting toxicities and the type, frequency, and severity of adverse events (AEs) to evaluate safety and tolerability and determine the recommended Phase 2 dose.

  • Secondary endpoints include overall response rate, duration of response, event-free survival, and overall survival to assess preliminary efficacy signals. Additionally, the pharmacokinetics of CAR-T cells will be analyzed to determine the expansion and persistence of TCX-001.

    Exploratory endpoints include changes in biomarkers and the expression of Siglec-6 on AML and CLL cells.