ArticleJournal for immunotherapy of cancer2022
Automated, scaled, transposon-based production of CAR T cells.
Article in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
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Who cites it
29 citing papers in PubMed, 43 citations in OpenAlex.
- Discovery of candidate antibodies and antigens for acute myeloid leukemia therapy by combining whole-cell phage display selection and CRISPR-Cas9 library screening.Antibody therapeutics · 2026Article
- Cationic mRNA Lipid Nanoparticles for Ex Vivo NanoCAR-T Cell Engineering.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- CAR-T therapy for autoimmune rheumatic diseases: navigating clinical frontiers between breakthroughs and uncertainties.Clinical and experimental medicine · 2026Review
- Nanoparticles-enhanced CAR-T cell therapy: current advances and future directions.Biomarker research · 2026Review
- Research advances and application prospects of CAR-T therapy in the treatment of age-related diseases.Frontiers in immunology · 2026Review
- Advancing breast cancer treatment through dual targeting CAR T cell therapy.Discover oncology · 2025Review
- In vivo CAR-T cell engineering: concept, research progress, potential challenges and enhancement strategies.Experimental hematology & oncology · 2025Review
- Recent advances in immunotherapy for breast cancer.Discover oncology · 2025Review
- Cost-effective strategies for CAR-T cell therapy manufacturing.Molecular therapy. Oncology · 2025Review
- Living Medicines Engineered to Fight: A Comprehensive Review on CAR T-Cell Therapy.International journal of hematology-oncology and stem cell research · 2025Review
- CAR-T Cell Manufacturing for Hematological and Solid Tumors: From the Preclinical to Clinical Point of View.Cancer medicine · 2025Review
- "Attack!" Cellular Therapies to Attack Pathogens and Tumors.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2025Article
- New insights on potency assays from recent advances and discoveries in CAR T-cell therapy.Frontiers in immunology · 2025Review
- CGT 4.0: a distant dream or inevitable future? Smart process automation is critical to make efficient scalability of CGT manufacturing a reality.Frontiers in bioengineering and biotechnology · 2025Article
- The new era of immunotherapy for breast cancer: challenges and coping strategies of CAR-T cell therapy.Frontiers in immunology · 2025Review
- Current Non-Viral-Based Strategies to Manufacture CAR-T Cells.International journal of molecular sciences · 2024Review
- Cas9-induced targeted integration of large DNA payloads in primary human T cells via homology-mediated end-joining DNA repair.Nature biomedical engineering · 2024Article
- Advanced strategies in improving the immunotherapeutic effect of CAR-T cell therapy.Molecular oncology · 2024Review
- Automated manufacture of ΔNPM1 TCR-engineered T cells for AML therapy.Molecular therapy. Methods & clinical development · 2024Article
- Novel insights into TCR-T cell therapy in solid neoplasms: optimizing adoptive immunotherapy.Experimental hematology & oncology · 2024Review
Corrections and comments
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Authors and funding
18 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is an increasing demand for chimeric antigen receptor (CAR) T cell products from patients and care givers. Here, we established an automated manufacturing process for CAR T cells on the CliniMACS Prodigy platform that is scaled to provide therapeutic doses and achieves gene-transfer with virus-free Sleeping Beauty (SB) transposition.
methodsWe used an advanced CliniMACS Prodigy that is connected to an electroporator unit and performed a series of small-scale development and large-scale confirmation runs with primary human T cells. Transposition was accomplished with minicircle (MC) DNA-encoded SB100X transposase and pT2 transposon encoding a CD19 CAR.
resultsWe defined a bi-pulse electroporation shock with bi-directional and unidirectional electric field, respectively, that permitted efficient MC insertion and maintained a high frequency of viable T cells. In three large scale runs, 2E8 T cells were enriched from leukapheresis product, activated, gene-engineered and expanded to yield up to 3.5E9 total T cells/1.4E9 CAR-modified T cells within 12 days (CAR-modified T cells: 28.8%±12.3%). The resulting cell product contained highly pure T cells (97.3±1.6%) with balanced CD4/CD8 ratio and a high frequency of T cells with central memory phenotype (87.5%±10.4%). The transposon copy number was 7.0, 9.4 and 6.8 in runs #1-3, respectively, and gene analyses showed a balanced expression of activation/exhaustion markers. The CD19 CAR T cell product conferred potent anti-lymphoma reactivity in pre-clinical models. Notably, the operator hands-on-time was substantially reduced compared with conventional non-automated CAR T cell manufacturing campaigns.
conclusionsWe report on the first automated transposon-based manufacturing process for CAR T cells that is ready for formal validation and use in clinical manufacturing campaigns. This process and platform have the potential to facilitate access of patients to CAR T cell therapy and to accelerate scaled, multiplexed manufacturing both in the academic and industry setting.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.