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), myelodysplastic syndrome (MDS) or multiple myeloma (MM).
ClinicalTrials.gov: TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms
| Status | Recruiting |
| 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) |
| Enrollment | Up 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 |
| Indications | Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), multiple myeloma (MM) |
| Preliminary Phase I data |