ArticleMolecular therapy : the journal of the American Society of Gene Therapy2018
Absence of Replication-Competent Lentivirus in the Clinic: Analysis of Infused T Cell Products.
Article in Molecular therapy : the journal of the American Society of Gene Therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05241444 (Phase 1 Study of Autologous CD4^LVFOXP3 in Participants With Immune Dysregulation Polyendocrinopathy Enteropathy X-linked), which is not on this map. Cited by 52 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
Phase 1 Study of Autologous CD4^LVFOXP3 in Participants With Immune Dysregulation Polyendocrinopathy Enteropathy X-linked (IPEX) Syndrome
Who cites it
52 citing papers in PubMed, 96 citations in OpenAlex.
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- Encoding and decoding selectivity and promiscuity in the human chemokine-GPCR interaction network.Cell · 2025Article
- Optimizing viral transduction in immune cell therapy manufacturing: key process design considerations.Journal of translational medicine · 2025Review
- Effects of an Initial Anti-CD19 CAR T-cell Therapy on Subsequent Anti-CD22 CAR T-cell Manufacturing and Clinical Outcomes in Patients with Relapsed/Refractory LBCL.Cancer discovery · 2025Article
- Long-term safety of lentiviral or gammaretroviral gene-modified T cell therapies.Nature medicine · 2025Article
- Review
- Influence of CAR T-cell therapy associated complications.Frontiers in oncology · 2025Review
- Skin Disorders and Osteoporosis: Unraveling the Interplay Between Vitamin D, Microbiota, and Epigenetics Within the Skin-Bone Axis.International journal of molecular sciences · 2024Review
- Product Enhanced Reverse Transcriptase for assessing replication competent virus in vectors retroviral vectors pseudotyped with GALV and VSV-G envelopes.Journal of virological methods · 2024Article
- False-positive human immunodeficiency virus nuclear acid amplification technique testing following therapy with transgenic T cell receptor cellular therapy for synovial sarcoma.Bone marrow transplantation · 2024Article
- Risk of T-cell malignancy after CAR T-cell therapy in children, adolescents, and young adults.Blood advances · 2024Article
- Answering the "Doctor, can CAR-T therapy cause cancer?" question in clinic.Blood advances · 2024Article
- CAR-T cell manufacturing: Major process parameters and next-generation strategies.The Journal of experimental medicine · 2024Review
- Effectiveness of CAR-T treatment toward the potential risk of second malignancies.Frontiers in immunology · 2024Article
- Long-term follow-up of CD19-CAR T-cell therapy in children and young adults with B-ALL.Hematology. American Society of Hematology. Education Program · 2023Review
- Myelodysplastic Syndrome After Anti-CD19 Chimeric Antigen Receptor T-cell Therapy: A Case Series.Cureus · 2023Article
- piggyBac-transposon-mediated CAR-T cells for the treatment of hematological and solid malignancies.International journal of clinical oncology · 2023Review
- Meeting FDA Guidance recommendations for replication-competent virus and insertional oncogenesis testing.Molecular therapy. Methods & clinical development · 2023Review
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Authors and funding
10 authors at 7 institutions in 1 country.
Funding
Abstract
Exposure to replication-competent lentivirus (RCL) is a theoretical safety concern for individuals treated with lentiviral gene therapy. For certain ex vivo gene therapy applications, including cancer immunotherapy trials, RCL detection assays are used to screen the vector product as well as the vector-transduced cells. In this study, we reviewed T cell products screened for RCL using methodology developed in the National Gene Vector Biorepository. All trials utilized third-generation lentiviral vectors produced by transient transfection. Samples from 26 clinical trials totaling 460 transduced cell products from 375 subjects were evaluated. All cell products were negative for RCL. A total of 296 of the clinical trial participants were screened for RCL at least 1 month after infusion of the cell product. No research subject has shown evidence of RCL infection. These findings provide further evidence attesting to the safety of third-generation lentiviral vectors and that testing T cell products for RCL does not provide added value to screening the lentiviral vector product.
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What OpenQuestion holds
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.