ArticleThe AAPS journal2021
Insights on Droplet Digital PCR-Based Cellular Kinetics and Biodistribution Assay Support for CAR-T Cell Therapy.
Article in The AAPS journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 15 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed.
- Case study of CD19 CAR T therapy in a subject with immune-mediate necrotizing myopathy treated in the RESET-Myositis phase I/II trial.Molecular therapy : the journal of the American Society of Gene Therapy · 2024Trial
- Impact of Extraction Recovery and Matrix Effect on qPCR-based Biodistribution Analysis in Gene Therapy: Strategies for Mitigation.The AAPS journal · 2026Article
- Case study of resecabtagene autoleucel in a subject with diffuse cutaneous systemic sclerosis treated in the RESET-SSc trial.Molecular therapy. Advances · 2026Article
- Method validation and assessment of the biodistribution and shedding for adenovirus vector-based vaccine using qPCR and dPCR.Molecular therapy. Methods & clinical development · 2025Article
- Quantitative pharmacology of dual-targeted bicistronic CAR-T-cell therapy using multiscale mechanistic modeling.CPT: pharmacometrics & systems pharmacology · 2025Article
- Quality assessment strategy development and analytical method selection of GMP grade biological drugs for gene and cell therapy.BBA advances · 2025Review
- A Comprehensive ddPCR Strategy for Sensitive and Reliable Monitoring of CAR-T Cell Kinetics in Clinical Applications.International journal of molecular sciences · 2024Article
- Development and validation of a model gene therapy biodistribution assay for AVGN7 using digital droplet polymerase chain reaction.Molecular therapy. Methods & clinical development · 2023Article
- CAR T-Cell Persistence Correlates with Improved Outcome in Patients with B-Cell Lymphoma.International journal of molecular sciences · 2023Article
- Novel Cell Quantification Method Using a Single Surrogate Calibration Curve Across Various Biological Samples.The AAPS journal · 2023Article
- Next generation multiplexing for digital PCR using a novel melt-based hairpin probe design.Frontiers in genetics · 2023Article
- Digital polymerase chain reaction strategies for accurate and precise detection of vector copy number in chimeric antigen receptor T-cell products.Cytotherapy · 2023Article
- Bioanalytical Assay Strategies and Considerations for Measuring Cellular Kinetics.International journal of molecular sciences · 2022Review
- Development of anti-somatostatin receptors CAR T cells for treatment of neuroendocrine tumors.Journal for immunotherapy of cancer · 2022Article
- Quantification of cell-free DNAfor the analysis of CD19-CAR-T cells during lymphoma treatment.Molecular therapy. Methods & clinical development · 2021Article
Corrections and comments
- Erratum issued
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Characterizing in vivo cellular kinetics and biodistribution of chimeric antigen receptor T (CAR-T) cells is critical for toxicity assessment, nonclinical and clinical efficacy studies. To date, the standardized assay to characterize CAR-T cell distribution, expansion, contraction, and persistence profiles is not readily available. To overcome this limitation and increase comparability among studies, we have established a universal protocol for analysis. We established a duplexing ddPCR protocol for the CAR-T transgene and reference gene to normalize the genomic DNA input prepared from mouse blood and tissues. The high-throughput gDNA extraction method enabled highly reproducible gDNA extraction while eliminating labor-intensive steps. The investigational CAR-T cells were intravenously injected into immunodeficient mice bearing human colorectal cancer xenografts. The blood and tissue samples were collected to measure the cellular kinetics by ddPCR and flow cytometry. The standard curves were linear throughout the calibration range with acceptable intra- and inter-day precision and accuracy. The gDNA recovery study performed by spiking in the exo-gene plasmid DNA or CAR-T cells revealed that the recovery ranged from 60 to 100% in blood and tissue homogenates. The use of both units of copy/μg gDNA and copy/μL blood met the current regulatory requirement and allowed for a systematic understanding of CAR-T cell expansion and a direct comparison with the flow cytometry data. A standardized ddPCR assay, including automated gDNA extraction procedures, has been established for evaluating cellular kinetics and biodistribution in CAR-T cell therapies.
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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.