ArticleBlood cancer journal2025
Risk factors for CAR T-cell manufacturing failure and patient outcomes in large B-cell lymphoma: a report from the UK National CAR T Panel.
Article in Blood cancer journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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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.
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Who cites it
18 citing papers in PubMed.
- Obinutuzumab plus bendamustine as first-line therapy for indolent B-cell lymphomas: a prospective multicenter open-label study.MedScience · 2026Trial
- Academic anti CD19 CAR-T cell therapy for relapsed/refractory B-cell lymphomas in real-world clinical practice: a prospective cohort study.Frontiers in oncology · 2026Trial
- Transduction efficiency in clinical CAR T cell products: A retrospective study at a single center.Molecular therapy. Advances · 2026Article
- Remodeling memory T cells with chemotherapy and immune checkpoint inhibitors as host pre-conditioning to empower in vivo CAR-T therapy.Synthetic and systems biotechnology · 2026Review
- Advancing In Vivo Chimeric Antigen Receptor T-Cell Engineering to Accelerate Clinical Translation.MedComm · 2026Review
- Institutional risk management for out-of-specification commercial CAR-T products.Bone marrow transplantation · 2026Article
- First-Line Bruton's Tyrosine Kinase Inhibitor-Based Regimens for Mantle Cell Lymphoma.Current oncology (Toronto, Ont.) · 2026Review
- CAR-NK cell therapy for hematological malignancies.Blood advances · 2026Review
- Current status and issues with CAR-T cell products in Japan: a regulatory perspective.International journal of hematology · 2026Review
- Adoptive T-cell therapies in the clinic.Bioengineering & translational medicine · 2026Review
- Dynamic estimation of metabolic state during CAR T cell production.Cell reports methods · 2026Article
- Process Systems Engineering in Precision Medicine: Opportunities in Autologous CAR-T Therapy.Engineering in life sciences · 2026Review
- Adapter-based allogeneic CAR T cells to overcome antigen escape in solid tumors.Frontiers in immunology · 2026Review
- CAR-T cell therapy for autoimmune diseases: current clinical trial landscape and the next wave of development.Frontiers in immunology · 2026Review
- Peripheral Blood CD4/CD8 Ratio Predicts Out-of-Specification Products in Lisocabtagene Maraleucel Manufacturing.Cancer reports (Hoboken, N.J.) · 2025Article
- Review
- [Bendamustine combined with anti-CD20 monoclonal antibody in the first-line treatment of older patients with indolent B-cell non-Hodgkin lymphoma: a multicenter retrospective study].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025Article
- Challenges and opportunities in the compassionate use of out-of-specification products in autologous regenerative medicine.Stem cell research & therapy · 2025Review
Corrections and comments
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Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
CAR T-cell manufacturing failure (MF) is a situation where the manufacturing process fails to yield a product or results in one which is out-of-specification (OOS). We conducted a multicentre retrospective review of factors contributing to MF and patient outcomes. Of 981 large B-cell lymphoma (LBCL) patients approved for CAR T-cell therapy, 38 (3.87%) had MF. Eleven patients received delayed infusion with a product in-specification (delayed-infused) following 21 remanufacturing attempts. OOS product was infused in 13 (OOS-infused), and 14 were not infused. For comparison, we included 38 LBCL controls without MF; 29 received infusion (controls-infused). Prior bendamustine was the only baseline variable associated with MF risk, largely due to therapy within 6 months; 23.7% MF vs 0% controls (P = 0.0029). Overall survival (OS) and progression-free survival (PFS) were not significantly different for infused patients, with 1-year OS (PFS) of 52.8% (46.2%), 46.8% (24.2%) and 68.4% (41.4%) for OOS-infused, delayed-infused and controls-infused respectively (PFS HR OOS-infused vs controls-infused 1.41, P = 0.40; delayed-infused vs controls-infused 1.64, P = 0.25; and OOS-infused vs delayed-infused 0.86, P = 0.76). CRS, ICANS and cytopenias were not significantly different between cohorts. Outcomes for OOS-infused LBCL patients following MF are encouraging. Remanufacturing led to infusion of a product in-specification in around 50% and may be an option for patients where a suitable OOS product is not available.
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Registered trials
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