Cytotherapy最新文献

{"title":"Bone marrow grafts on demand","authors":"Edwin M. Horwitz","doi":"10.1016/j.jcyt.2025.102000","DOIUrl":"10.1016/j.jcyt.2025.102000","url":null,"abstract":"","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"28 2","pages":"Article 102000"},"PeriodicalIF":3.2,"publicationDate":"2025-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145656188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognostic factors and outcomes of tisagenlecleucel in relapsed or refractory B-cell malignancies: a single-center real-world study","authors":"Soo Jung Lee ,&nbsp;Gi June Min ,&nbsp;Sung-Soo Park ,&nbsp;Youngwoo Jeon ,&nbsp;Jae Won Yoo ,&nbsp;Dong Wook Jekarl ,&nbsp;Jae Wook Lee ,&nbsp;Ki-Seong Eom ,&nbsp;Nack-Gyun Chung ,&nbsp;Chang-Ki Min ,&nbsp;Seok-Goo Cho ,&nbsp;Yonggoo Kim ,&nbsp;Jae-Ho Yoon","doi":"10.1016/j.jcyt.2025.102002","DOIUrl":"10.1016/j.jcyt.2025.102002","url":null,"abstract":"<div><h3>Background</h3><div>Tisagenlecleucel (tisa-cel), a CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy, is an approved treatment for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and B-cell precursor acute lymphoblastic leukemia (B-ALL). While pivotal trials demonstrated its efficacy, real-world evidence from Asian populations remains scarce. In particular, data on manufacturing feasibility, clinical outcomes, and predictive biomarkers in Korean patients are limited.</div></div><div><h3>Objective</h3><div>This study aimed to evaluate the clinical outcomes and prognostic factors of tisa-cel therapy in Korean patients with R/R DLBCL and B-ALL, with a specific focus on apheresis product quality and baseline immune markers.</div></div><div><h3>Study design</h3><div>A single-center retrospective study was conducted including 91 patients (DLBCL = 72; B-ALL = 19) intended to receive tisa-cel between April 2022 and April 2024. Apheresis data, treatment responses, survival outcomes, and toxicity profiles were analyzed. The intention-to-treat (ITT) cohort was defined from the time of apheresis. Cox regression was used to identify predictors of survival and relapse, and separate analyses were performed for DLBCL and B-ALL.</div></div><div><h3>Results</h3><div>Out of 91 patients, 72 received tisa-cel infusion. One-year overall survival (OS) and disease-free survival (DFS) for the entire ITT cohort were 45.9% and 37.5%, respectively. In 19 B-ALL after tisa-cel infusion, 1-year OS and DFS were 68.4% and 52.6%, with no non-relapse mortality (NRM). In 53 DLBCL after tisa-cel infusion, 1-year OS and DFS were 46.8% and 41.6%, respectively, with 29.6% cumulative incidence of relapse among responders. NRM was 9.5% mostly observed in elderly patients. In the DLBCL subgroup, poor OS was independently associated with third-or-later-line salvage therapy (hazard ratio [HR] 2.39), high peripheral blood monocyte proportion at apheresis (&gt;10%, HR 2.57), low CD3+ T-cell concentration in apheresis product (&lt;1.0×10⁸/mL, HR 4.31), and occurrence of immune effector cell-associated neurotoxicity syndrome (HR 2.47). B-ALL patients demonstrated favorable survival and lower toxicity, but no significant prognostic markers were identified.</div></div><div><h3>Conclusions</h3><div>Tisa-cel therapy was feasible and effective in Korean patients with R/R B-cell malignancies. Pre-treatment immune parameters such as monocyte burden and CD3+ T-cell quality in apheresis products significantly influenced outcomes in DLBCL. These findings suggest that optimizing patient selection and refining manufacturing strategies may enhance CAR-T efficacy, particularly in resource-constrained or heterogeneous real-world settings.</div></div>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"28 2","pages":"Article 102002"},"PeriodicalIF":3.2,"publicationDate":"2025-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145652079","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A FOXP3+ cell-rich microenvironment associates with better overall survival after CAR-T cell therapy in relapsed/refractory B-cell lymphoma","authors":"Simone Zanella ,&nbsp;Cristina Zucchinetti ,&nbsp;Chiara de Philippis ,&nbsp;Daniele Mannina ,&nbsp;Daniela Taurino ,&nbsp;Jacopo Mariotti ,&nbsp;Barbara Sarina ,&nbsp;Daoud Rahal ,&nbsp;Carmelo Carlo-Stella ,&nbsp;Armando Santoro ,&nbsp;Arturo Bonometti ,&nbsp;Stefania Bramanti","doi":"10.1016/j.jcyt.2025.10.007","DOIUrl":"10.1016/j.jcyt.2025.10.007","url":null,"abstract":"<div><div>CAR-T cell therapy has revolutionized the treatment of non-Hodgkin B-lymphomas, but relapse rates remain unacceptably high, and resistance mechanisms are still unclear. A key challenge of T-cell−based therapy is the immune-suppressive tumor microenvironment, which is rich in immune-suppressive cells, including regulatory T cells (Tregs). Tregs express FOXP3, CD3 and CD25, and their role in B-cell lymphomas treated with CAR-T cells remains uncertain. Using immunohistochemistry, we analyzed 31 pre-infusion and seven post-infusion paired biopsies from patients with relapsed/refractory B-cell lymphoma who received CAR-T cell therapy. Pre- infusion FOXP3+ cell percentages were assessed and correlated with response rate, progression-free survival (PFS), and overall survival (OS). Post-infusion biopsies were examined for FOXP3 changes. We identified 3% as the optimal FOXP3+ cut-off, defining low (≤3%) and high (&gt;3%) FOXP3 groups. Patients with high FOXP3 had a better OS (1-year OS 94% versus 61%, <em>P</em> = 0.006). PFS also favored high FOXP3 patients but lacked statistical significance (1-year PFS 65% versus 54%, <em>P</em> = 0.41). Notably, relapsed patients with high FOXP3 maintained high expression and responded better to subsequent treatments (<em>P</em> = 0.03). Our findings highlight the impact of tumor-infiltrating Tregs on CAR-T cell efficacy in lymphomas.</div></div>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"28 3","pages":"Article 101997"},"PeriodicalIF":3.2,"publicationDate":"2025-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145524579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Crowdfunding for cellular and gene therapy products","authors":"Jeremy Snyder","doi":"10.1016/j.jcyt.2025.10.005","DOIUrl":"10.1016/j.jcyt.2025.10.005","url":null,"abstract":"<div><h3>Background Aims</h3><div>Cellular and gene therapy products provide hope to people experiencing debilitating diseases. Many people seek to access these products ahead of regulatory approval through clinical trials, exceptional access programs, and direct to consumer purchases. Even when regulatory approval has been given, these products can cost millions of dollars in direct and indirect expenses. This study examines how crowdfunding campaigns are being used to pay for United States Federal Drug Administration (FDA) approved cellular and gene therapy products.</div></div><div><h3>Methods</h3><div>The author searched the GoFundMe crowdfunding platform for 43 FDA-approved cellular and gene therapy products. The campaign title, campaign text, funding requested, funding pledged, number of donations, campaign start date, and campaign location was collected for each campaign. Total 529 campaigns were identified and 322 included for content analysis as seeking funding to pay for the direct or indirect costs of accessing FDA-approved cellular or gene therapy products.</div></div><div><h3>Results</h3><div>Crowdfunding campaigns for 17 FDA-approved cellular and gene therapy products were identified. Total 322 campaigns raised $8,997,107.19 (median $3675.04) from 154,230 (72.5) donations out of $334,723,452.76 ($184,250) requested. Two campaigns raised 39.2% of all funds and 10 raised 64.8% of all funds. Fundraising goals ranged from $1.11–$12,000,000. The 4^th and 5^th largest quintiles of fundraising requests were over $1,200,000.</div></div><div><h3>Conclusions</h3><div>The median fundraising goal and funding received were larger than has been found in other studies of medical crowdfunding. Differences in fundraising goals and donations suggest inequities in insurance coverage and the ability to access cellular and gene therapy products.</div></div>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"28 1","pages":"Article 101995"},"PeriodicalIF":3.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145580047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Brain on the mend: induced mesenchymal stem cell−based therapies promote functional recovery in rats with neonatal hypoxic-ischemic brain injury","authors":"Inês Serrenho ,&nbsp;Sofia C. Serra ,&nbsp;António J. Salgado ,&nbsp;Graça Baltazar","doi":"10.1016/j.jcyt.2025.10.008","DOIUrl":"10.1016/j.jcyt.2025.10.008","url":null,"abstract":"<div><h3>Background aims</h3><div>Neonatal hypoxic-ischemic encephalopathy (HIE) remains a leading cause of infant mortality and long-term neurologic disability. Although therapeutic hypothermia (TH) is the current standard treatment, its effectiveness is limited, with many infants either ineligible or showing incomplete recovery. As a result, alternative therapies, such as mesenchymal stem cells (MSCs) derived from induced pluripotent stem cells (iMSCs), are being explored. iMSCs have shown considerable promise in preclinical studies because of their consistent properties, which help overcome some of the challenges associated with traditional MSCs. This study evaluated the efficacy of iMSCs and their secretome in promoting recovery after neonatal hypoxic-ischemic (HI) brain injury in a well-established rodent model.</div></div><div><h3>Methods</h3><div>The Rice-Vannucci model was used to induce HI brain injury to the developing brain on postnatal day 10 (P10) Wistar Han rat pups. Two days post-injury, 50 000 iMSCs or their secretome were administered intranasally. Over the next 30 days, motor and cognitive functions were assessed through a series of behavioral tests. In addition, brain lesion size, neurogenesis and glial reactivity were examined by immunohistochemistry to evaluate the extent of neurorepair and inflammation.</div></div><div><h3>Results</h3><div>HI-lesioned animals treated with intranasal iMSCs or their secretome demonstrated improved motor capabilities and enhanced recognition memory compared with untreated lesioned animals. Both iMSCs and their secretome administration led to a reduction in brain lesion size and increased neurogenesis in the hippocampus. Moreover, glial reactivity, including astrocyte and microglia activation, was significantly reduced 30 days after injury, suggesting a more favorable neuroinflammatory environment in treated groups.</div></div><div><h3>Conclusions</h3><div>These findings highlight the potential of iMSCs and their secretome to enhance functional recovery and reduce brain damage after neonatal HI. The similar therapeutic outcomes achieved with the iMSC secretome suggest that the secreted factors play a central role in driving neurorepair. More studies are still necessary to gain a better understanding of the mechanisms underlying iMSCs' neuroprotective and neuroreparative effects.</div></div>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"28 3","pages":"Article 101998"},"PeriodicalIF":3.2,"publicationDate":"2025-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145551696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Expanded adaptive NKG2C+ NK cells exhibit potent ADCC and functional responses against HBV-infected hepatoma cell lines","authors":"Jonida Kokiçi ,&nbsp;Helena Arellano-Ballestero ,&nbsp;Benjamin Hammond ,&nbsp;Anucha Preechanukul ,&nbsp;Noshin Hussain ,&nbsp;Kelly da Costa ,&nbsp;Jessica Davies ,&nbsp;Sadiyah Mukhtar ,&nbsp;Thomas Fernandez ,&nbsp;Sabine Kinloch ,&nbsp;Fiona M. Burns ,&nbsp;Patrick Kennedy ,&nbsp;Douglas MacDonald ,&nbsp;Mala K. Maini ,&nbsp;Upkar S. Gill ,&nbsp;Alan Xiaodong Zhuang ,&nbsp;Mark W. Lowdell ,&nbsp;Karl-Johan Malmberg ,&nbsp;Ebba Sohlberg ,&nbsp;Dimitra Peppa","doi":"10.1016/j.jcyt.2025.10.006","DOIUrl":"10.1016/j.jcyt.2025.10.006","url":null,"abstract":"<div><h3>Background</h3><div>Hepatitis B virus (HBV) infection remains a significant global health challenge, leading to chronic liver disease and hepatocellular carcinoma (HCC). Natural killer (NK) cells play an important role in the clearance of HBV-infected cells, but their efficacy is often compromised during chronic infection. Adaptive NK cells, characterized by NKG2C expression and enhanced functional responses, represent a promising therapeutic avenue for enhancing anti-HBV immunity and responses to HBV-driven cancers.</div></div><div><h3>Methods</h3><div>We applied an established protocol, involving K562-HLA-E expressing feeder cells and cytokines (IL-2), for the expansion of adaptive NK cells from cryopreserved T- and B cell depleted peripheral blood mononuclear cells (PBMCs) derived from donors with chronic HBV infection alone or with Human Immunodeficiency Virus (HIV) co-infection. We evaluated the adaptive profile of expanded NK cells, their antibody-dependent cellular cytotoxicity (ADCC) capacity and functional responses against hepatoma cell lines in the presence or absence of HBV infection.</div></div><div><h3>Results</h3><div>Expanded NK cells achieved &gt;97% purity, with the NKG2C positive population exhibiting a mean 100-fold expansion. These cells demonstrated a predominantly adaptive phenotype with high surface expression of NKG2C and cytotoxic potential (Granzyme B). They maintained high levels of CD16 surface expression and upregulated CD2, essential for ADCC. Functionally, expanded adaptive NK cells showed enhanced ADCC capacity and functional responses to K562 targets, naive, HBV integrant-expressing, and <em>de novo</em> infected hepatoma cell lines. TGF-β preconditioning induced tissue-resident features (CD103, CD49a) in expanded adaptive NK cells, while preserving their adaptive phenotype and functionality, enhancing their potential for liver targeted immunotherapy. Further, expanded adaptive NK cells demonstrated minimal reactivity against autologous activated T cells, suggesting limited off-target effects.</div></div><div><h3>Conclusions</h3><div>Our study demonstrates the first successful expansion of adaptive NK cells with robust functional responses from donors with chronic viral infection. This approach creates opportunities for NK cell-based therapies alone or in combination with monoclonal antibodies contributing to HBV functional cure strategies and the treatment of HBV-driven cancers.</div></div>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"28 3","pages":"Article 101996"},"PeriodicalIF":3.2,"publicationDate":"2025-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145710268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Single-cell transcriptomics reveals dynamics of natural killer cell expansion in a feeder cell-free culture of peripheral blood mononuclear cells—implications for immunotherapy","authors":"Brian Ladd ,&nbsp;Markella Zacharouli ,&nbsp;Per-Henrik Holmqvist ,&nbsp;Stefanie Renken ,&nbsp;Pontus Blomberg ,&nbsp;Véronique Chotteau","doi":"10.1016/j.jcyt.2025.10.004","DOIUrl":"10.1016/j.jcyt.2025.10.004","url":null,"abstract":"<div><div>Natural killer (NK) cell therapies hold great promise for cancer treatment; however, donor-to-donor heterogeneity in the <em>ex vivo</em> expansion process remains a critical bottleneck in their supply. This study aimed to identify factors influencing donor variability in a 2-week-long <em>ex vivo</em> NK cell expansion from peripheral blood mononuclear cells, analyzed across three donors. Single-cell transcriptomics was applied to investigate the distribution of cell types and phenotypes, as well as trajectory inference and differential gene expression. Our results identified that several factors were associated with the variability in the final NK cell fraction and expansion, and that their influence was prevalent between culture days 3 and 8. Compared to a high final NK cell expansion, a culture with a low final NK cell expansion exhibited an upregulation of some stress and inflammatory genes and an increase in one specific subcluster of NK cells already on culture day 3. It showed a low score of CD56^Bright CD16^– phenotype and a high score of CD56^Dim CD16⁺ phenotype. It also had a decreased presence of cytotoxic CD8⁺ Tm cells. Among the observed subclusters of CD8⁺ Tm cells, it exhibited a higher presence of a subcluster associated with a less differentiated and less cytotoxic phenotype, as well as a lower prevalence of a subcluster associated with chemokine and cytotoxic genes. Finally, it had a major expansion of one of the CD8⁺ Tm cells subclusters annotated as NK-like T cell and characterized by a high CCR5 mRNA expression, while the levels of CCL3, CCL4 and CCL5 mRNA were downregulated. The present findings point toward a potential link between CCL signaling and improved NK cell expansion performance, including possible markers for further investigations, and suggest future strategies to increase the final NK cell fraction and expansion based on donor-specific markers.</div></div>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"28 1","pages":"Article 101994"},"PeriodicalIF":3.2,"publicationDate":"2025-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145624293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Subscription information","authors":"","doi":"10.1016/S1465-3249(25)00856-4","DOIUrl":"10.1016/S1465-3249(25)00856-4","url":null,"abstract":"","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"27 11","pages":"Page A5"},"PeriodicalIF":3.2,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145340546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aims and Scope","authors":"","doi":"10.1016/S1465-3249(25)00853-9","DOIUrl":"10.1016/S1465-3249(25)00853-9","url":null,"abstract":"","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"27 11","pages":"Page A1"},"PeriodicalIF":3.2,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145340543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pilot study of early BK polyomavirus in the urine and risk of hemorrhagic cystitis after allogeneic hematopoietic cell transplantation","authors":"Yeon Joo Lee ,&nbsp;Yuxuan Li ,&nbsp;Michael Scordo ,&nbsp;Gyuri Han ,&nbsp;Ilya Glezerman ,&nbsp;Brian Shaffer ,&nbsp;Sergio A. Giralt ,&nbsp;Esperanza B. Papadopoulos ,&nbsp;Miguel-Angel Perales ,&nbsp;Ann A. Jakubowski ,&nbsp;Genovefa A. Papanicolaou","doi":"10.1016/j.jcyt.2025.10.003","DOIUrl":"10.1016/j.jcyt.2025.10.003","url":null,"abstract":"<div><h3>Background</h3><div>BK polyomavirus (BKPyV)-associated hemorrhagic cystitis occurs in 7–60% of allogeneic hematopoietic cell transplantation (HCT) recipients and may cause significant morbidity.</div></div><div><h3>Objective</h3><div>We conducted a pilot study to assess if early BKPyV viruria (≤day [D]+40 post-HCT) predicted risk for BKPyV hemorrhagic cystitis in the first year post-HCT.</div></div><div><h3>Study Design</h3><div>Adult consecutive allogeneic HCT recipients at Memorial Sloan Kettering Cancer Center from August 2019 through April 2021 were screened for urine BKPyV quantitative PCR (Eurofins Viracor, Lenexa, KS) between D-14 and D0 (pre-HCT). If the pretransplant test was negative, urine BKPyV was retested between D+20 and D+40 postengraftment. If the pre-HCT test was positive, repeat postengraftment testing was not performed. Patients with early BKPyV viruria were monitored by plasma BKPyV quantitative PCR bimonthly for the first 6 months post-HCT or 12 months post-HCT in patients with graft-versus-host disease requiring systemic corticosteroids. Patients were followed clinically for the development of BKPyV hemorrhagic cystitis in the first year post-HCT. Urine BKPyV PCR was checked per standard of care if patients developed symptoms of cystitis. BKPyV hemorrhagic cystitis was defined as BKPyV viruria with macroscopic hematuria and symptoms of cystitis. Risk factors for BKPyV hemorrhagic cystitis were examined using logistic regression models.</div></div><div><h3>Results</h3><div>Of 152 patients analyzed, 73 (48%) had early BKPyV viruria (33 pre-HCT and 40 post-HCT). Nine patients developed BKPyV hemorrhagic cystitis before D+40, and 7 patients after D+40. Among the 79 patients without early BKPyV viruria, none developed BKPyV hemorrhagic cystitis. The cumulative incidence of BKPyV hemorrhagic cystitis by 1-year post-HCT was 10% (95% confidence interval: 0.051–0.146). Cut point analysis demonstrated that BKPyV urine viral load ≥6.35 × 10⁶ copies/mL was the optimal discriminator for BKPyV hemorrhagic cystitis at 1-year post-transplant (odds ratio: 7.59, 95% confidence interval: 2.27, 27.2; <em>P</em> = .001).</div></div><div><h3>Conclusions</h3><div>Nearly half of HCT patients had BKPyV viruria by D+40 post-HCT. Early BKPyV viruria ≥6.35 × 10⁶ copies/mL may help identify patients at risk for BKPyV hemorrhagic cystitis. Clinical trials of BKV therapeutics may use early BKPyV screening to identify patients at high-risk for BKPyV hemorrhagic cystitis.</div></div>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"28 3","pages":"Article 101993"},"PeriodicalIF":3.2,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145446497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}