ArticleMolecular therapy : the journal of the American Society of Gene Therapy2020
TEG001 Insert Integrity from Vector Producer Cells until Medicinal Product.
Article in Molecular therapy : the journal of the American Society of Gene Therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Harmonisation of quality control tests for academic production of CAR-T cells: a position paper from the WP-bioproduction of the UNITC consortium.Bone marrow transplantation · 2025Guideline
- T cell immunotherapy for solid tumors: limitations, progress, and future prospects.Frontiers in immunology · 2026Review
- Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit.Immuno-oncology technology · 2023Review
- Gamma delta TCR anti-CD3 bispecific molecules (GABs) as novel immunotherapeutic compounds.Journal for immunotherapy of cancer · 2021Article
- Characterization and modulation of anti-αβTCR antibodies and their respective binding sites at the βTCR chain to enrich engineered T cells.Molecular therapy. Methods & clinical development · 2021Article
- Review
- Allogeneic Stem Cell Transplantation Platforms With Ex Vivo and In Vivo Immune Manipulations: Count and Adjust.HemaSphere · 2021Review
- Adding Help to an HLA-A*24:02 Tumor-Reactive γδTCR Increases Tumor Control.Frontiers in immunology · 2021Article
- γ9δ2T cell diversity and the receptor interface with tumor cells.The Journal of clinical investigation · 2020Article
- TEG011 persistence averts extramedullary tumor growth without exerting off-target toxicity against healthy tissues in a humanized HLA-A*24:02 transgenic mice.Journal of leukocyte biology · 2020Article
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11 authors.
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Abstract
Despite extensive usage of gene therapy medicinal products (GTMPs) in clinical studies and recent approval of chimeric antigen receptor (CAR) T cell therapy, little information has been made available on the precise molecular characterization and possible variations in terms of insert integrity and vector copy numbers of different GTMPs during the complete production chain. Within this context, we characterize αβT cells engineered to express a defined γδT cell engineered to express a defined γδT receptor (TEG) currently used in a first-in-human clinical study (NTR6541). Utilizing targeted locus amplification in combination with next generation sequencing for the vector producer clone and TEG001 products, we report on five single-nucleotide variants and nine intact vector copies integrated in the producer clone. The vector copy number in TEG001 cells was on average a factor 0.72 (SD 0.11) below that of the producer cell clone. All nucleotide variants were transferred to TEG001 without having an effect on cellular proliferation during extensive in vitro culture. Based on an environmental risk assessment of the five nucleotide variants present in the non-coding viral region of the TEG001 insert, there was no altered environmental impact of TEG001 cells. We conclude that TEG001 cells do not have an increased risk for malignant transformation in vivo.
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