ArticleJournal of translational medicine2020
Application of droplet digital PCR for the detection of vector copy number in clinical CAR/TCR T cell products.
Article in Journal of translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
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Who cites it
27 citing papers in PubMed, 37 citations in OpenAlex.
- Transduction efficiency in clinical CAR T cell products: A retrospective study at a single center.Molecular therapy. Advances · 2026Article
- Letter to the Editor regarding "Development of a 3-day manufacturing method to generate CD19-CD20-CD22 trispecific CAR T-cells from whole blood".Journal of translational medicine · 2026Article
- A single-cell multi-omics assay for simultaneous measurement of vector copy number and protein expression in CAR T cells.Molecular therapy. Advances · 2026Article
- Impact of vector copy number on critical quality attributes of retrovirally engineered T cells.Molecular therapy : the journal of the American Society of Gene Therapy · 2026Article
- Comparative pharmacokinetic derivations for axicabtagene ciloleucel and brexucabtagene autoleucel in the treatment of B cell malignancies.Molecular therapy. Advances · 2026Article
- Preventing secondary primary malignancies (SPMs) in CAR-T cell therapy through site-specific transgene integration into genomic safe harbors (GSHs).Journal of translational medicine · 2025Review
- Review
- Absolute quantification of rare gene targets in limited samples using crude lysate and ddPCR.Scientific reports · 2025Article
- An adjusted droplet digital PCR assay for quantification of vector copy number in CAR-T cell and TCR-T cell products.Immuno-oncology technology · 2025Article
- Regulatory T cell therapies: from patient data to biological insights.Frontiers in immunology · 2025Review
- New insights on potency assays from recent advances and discoveries in CAR T-cell therapy.Frontiers in immunology · 2025Review
- Development and validation of a droplet digital PCR method for quantifying lentiviral vector infectious titer.Heliyon · 2024Article
- Quantification of circulating TCR-engineered T cells targeting a human endogenous retrovirus post-adoptive transfer using nanoplate digital PCR.Molecular therapy. Methods & clinical development · 2024Article
- Universal ddPCR-based assay for the determination of lentivirus infectious titer and lenti-modified cell vector copy number.Molecular therapy. Methods & clinical development · 2023Article
- Detection and quantification of integrated vector copy number by multiplex droplet digital PCR in dual-transduced CAR T cells.Molecular therapy. Methods & clinical development · 2023Article
- Validation of a High-Sensitivity Assay for Detection of Chimeric Antigen Receptor T-Cell Vectors Using Low-Partition Digital PCR Technology.The Journal of molecular diagnostics : JMD · 2023Article
- Reference gene selection for clinical chimeric antigen receptor T-cell product vector copy number assays.Cytotherapy · 2023Article
- CAR T-Cell Persistence Correlates with Improved Outcome in Patients with B-Cell Lymphoma.International journal of molecular sciences · 2023Article
- Digital polymerase chain reaction strategies for accurate and precise detection of vector copy number in chimeric antigen receptor T-cell products.Cytotherapy · 2023Article
- The Evolving Landscape of Potency Assays.Advances in experimental medicine and biology · 2023Article
Corrections and comments
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Authors and funding
13 authors at 1 institution in 1 country.
Funding
Abstract
backgroundGenetically engineered T cells have become an important therapy for B-cell malignancies. Measuring the efficiency of vector integration into the T cell genome is important for assessing the potency and safety of these cancer immunotherapies.
methodsA digital droplet polymerase chain reaction (ddPCR) assay was developed and evaluated for assessing the average number of lenti- and retroviral vectors integrated into Chimeric Antigen Receptor (CAR) and T Cell Receptor (TCR)-engineered T cells.
resultsThe ddPCR assay consistently measured the concentration of an empty vector in solution and the average number of CAR and TCR vectors integrated into T cell populations. There was a linear relationship between the average vector copy number per cell measured by ddPCR and the proportion of cells transduced as measured by flow cytometry. Similar vector copy number measurements were obtained by different staff using the ddPCR assay, highlighting the assays reproducibility among technicians. Analysis of fresh and cryopreserved CAR T and TCR engineered T cells yielded similar results.
conclusionsddPCR is a robust tool for accurate quantitation of average vector copy number in CAR and TCR engineered T cells. The assay is also applicable to other types of genetically engineered cells including Natural Killer cells and hematopoietic stem cells.
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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.