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

Safety Clinical Trial

Official title: A Phase I/II, Open-Label, Non-Randomized, Multicentre, Dose-Escalation Clinical Trial With Control Group to Evaluate the Safety, Feasibility and Preliminary Efficacy of PRAME TCR Modified T Cells, MDG1011, in Subjects With High Risk Myeloid and Lymphoid Neoplasms

Status Terminated

Clinical Trial 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).

Clinical Trial Description

Phase I:

The Phase I dose escalation part will establish the MTD/RP2D in subjects with high risk myeloid and lymphoid neoplasms, a total of 3 disease entities.

Phase I subjects will be enrolled into the following cohorts and treated with a single intravenous (i.v.) infusion of IMP:

• Cohort 1: target dose of 1 x 105 T cells/kg ± 20%

• Cohort 2: target dose of 1 x 106 T cells/kg ± 20%

• Cohort 3: target dose of 5 x 106 T cells/kg ± 20%

• Optional cohort 4: up to 1 x 107 T cells/kg + 20%

Phase II:

The Phase II part consists of two arms, each representing one disease entity. Within each arm, representing a disease entity, subjects will be enrolled in 2 different treatment groups to receive either:

1. IMP in the treatment group (up to 20 subjects who are positive for human leukocyte antigen (HLA)-A*02:01); Or

2. therapy as per Investigator's discretion in the concurrent control (up to 20 subjects who are negative for HLA-A*02:01). ;

Related Conditions & MeSH terms

• Feasibility
• Neoplasms
• Safety
• Tolerability
• Treatment Efficacy

• NCT number: NCT03503968
• Study type: Interventional
• Source: Medigene AG
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 27, 2018
• Completion date: July 15, 2022