NCT03503968

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Medigene AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Safety
• Tolerability
• Feasibility
• Treatment Efficacy

Interventions

Type	Name	Description
DRUG	MDG1011	PRAME-T-Cell Receptor Gene Modified Autologous T Cells
OTHER	Investigator Choice therapy	Any intervention/therapy chosen by the investigator

Timeline

• Start date: 2018-03-27
• Primary completion: 2022-06-28
• Completion: 2022-07-15
• First posted: 2018-04-20
• Last updated: 2023-02-15

Locations

9 sites across 1 country: Germany