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

Safety and feasibility

Efficacy and immune monitoring