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Logo Made in Germany BIO 2018

Start of clinical trial with TCR immunotherapy MDG1011

Target:
PRAME (Preferentially Expressed Antigen in Melanoma) is a well characterized tumor antigen overexpressed in multiple hematological and solid tumor indications

The drug, MDG1011:
T cells expressing a HLA-A*02:01-restricted T cell receptor (TCR) specific for PRAME

Trial outline:
1) Combined Phase I/II safety, feasibility and early efficacy clinical trial
2) Disease indications for Phase I, all in advanced stages:
- acute myeloid leukemia (AML)
- myelodysplastic syndrome (MDS)
- multiple myeloma (MM)
3) Two of the three indications will be carried over into Phase II

Phase I:
Primary endpoint:
1) Safety (incidence, severity of adverse events (AEs) at 3 months, maximum tolerated dose (MTD) based on dose limiting toxicities up to 28 days)
2) Feasibility (percent of patients receiving the planned dose) at 3 months

Secondary endpoints:
1) Safety (incidence, severity of AEs at 6 and 12 months)
2) Overall response rate (ORR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS), overall survival (OS), quality of life (QoL) and the correlation of PRAME expression with the antitumor response, measured at 3, 6 and 12 months

Phase II:
Co-primary endpoints:
1) Safety (incidence, severity of AEs) at 3 months
2) Efficacy (ORR) at 3 months

Secondary endpoints:
1) Safety (incidence, severity of AEs) at 6 and 12 months
2) ORR at 6 and 12 months, DoR, TTP, PFS, OS, QoL and the correlation of PRAME expression with the antitumor response at 3, 6 and 12 months

www.medigene.com/investors-media/

Exhibitor: Medigene AG

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