TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms
NCT03503968 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2023-02-15
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).
Conditions
- Safety
- Tolerability
- Feasibility
- Treatment Efficacy
Interventions
- DRUG
-
MDG1011
PRAME-T-Cell Receptor Gene Modified Autologous T Cells
- OTHER
-
Investigator Choice therapy
Any intervention/therapy chosen by the investigator
Sponsors & Collaborators
-
Medigene AG
lead INDUSTRY
Principal Investigators
-
Simone Thomas, PD Dr. med. · University Hospital Regensburg
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-27
- Primary Completion
- 2022-06-28
- Completion
- 2022-07-15
Countries
- Germany
Study Locations
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