TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms

Phase 1/2 Terminated 9 enrolled MediGene

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a multicentre, non-randomized, open-label, Phase I/II clinical trial of MDG1011, an investigational medicinal product (IMP), consisting of patient-derived autologous T cells, persistently transduced with a Preferentially Expressed Antigen in Melanoma (PRAME)-specific human leukocyte antigen (HLA)-A\*02:01-restricted T cell receptor (TCR).

Timeline

Start: 2018-03-27
Primary completion: 2022-06-28
Completion: 2022-07-15

Outcome

Outcome not reported

Stopped: “The clinical trial is terminated after the completion of phase I without moving to Phase II.”

Publications

Burdek M, Prinz PU, Mutze K, Tippmer S, Geiger C, Longinotti G, Schendel DJ. Characterization of a 3S PRAME VLD-Specific T Cell Receptor and Its Use in Investigational Medicinal Products for TCR-T Therapy of Patients with Myeloid Malignancies. Cancers (Basel). 2025 Jan 13;17(2):242. doi: 10.3390/cancers17020242.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MDG1011	Cell therapy	100000 cells/kg	Intravenous
Subject	MDG1011	Cell therapy	1e+06 cells/kg	Intravenous
Subject	MDG1011	Cell therapy	5e+06 cells/kg	Intravenous
Subject	MDG1011	Cell therapy	1e+07 cells/kg	Intravenous

Indications

No indication recorded.