TCR-T Immuntherapie MDG1011

Medigene commenced a Phase I/II clinical trial of MDG1011 in the first quarter of 2018. This clinical trial is the first clinical trial with a TCR-T therapy in Germany. The multi-center, open-label Phase I/II clinical trial treats blood cancer patients with advanced-stage acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Clinical trial phase

Phase I/II

Phase I is a dose escalation trial with approximately 12 patients, Phase II of 80 patients will contain control groups (40 of 80 patients)

EnrollmentUp to 92 patients
Primary endpoint

The primary endpoints for the Phase I portion of the clinical trial include safety at three months and the determination of the maximum tolerated dose and/or recommended Phase II dose of MDG1011 and feasibility

Co-primary endpoints of the Phase II portion of the clinical trial are safety and preliminary efficacy, where efficacy is measured as overall response rate (ORR) at three months.

Secondary endpoint

Several secondary endpoints including the overall response rate (ORR), the progression-free survival (PFS) rate, the overall survival (OS) rate and the time to progression (TTP) are assessed

IndicationsAcute myeloid leukemia (AML), myelodysplastic syndrome (MDS) TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms

Which patients with blood-cancer can participate?

In the Phase I portion of the clinical trial, approximately 12 patients who are suffering from advanced-stage disease and have previously undergone several cycles of standard therapies are being enrolled. Patients are screened for HLA-A*02:01 status and the expression of the PRAME antigen by their tumor cells. As a first step, an apheresis is performed to isolate the patient’s own T cells which are then modified with Medigene’s TCR specific for the PRAME antigen. After comprehensive quality testing of the resulting TCR-T cells, the patient undergoes a preparative chemotherapy and a one-time infusion of MDG1011. In the early stages of clinical development, Medigene expects a production time of about six weeks from the beginning of an apheresis process until completion of the cell product.

Where is the clinical trial being conducted?

For this “first-in-country” and “first-in-human” TCR-therapy clinical trial in Germany, Medigene has trained and activated different clinical trial sites to conduct this personalized cell therapy project. These university hospitals actively screen suitable patients and enroll them in the clinical trial:

  • Regensburg

  • Erlangen

  • Würzburg

  • Mainz

  • Freiburg

  • Frankfurt

  • Dresden

  • Heidelberg

  • Leipzig