Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021
Third-Party BK Virus-Specific Cytotoxic T Lymphocyte Therapy for Hemorrhagic Cystitis Following Allotransplantation.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection
A Prospective Clinical Study to Evaluate the Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.
- Risk factors for hemorrhagic cystitis in children undergoing hematopoietic stem cell transplantation: a systematic review and meta-analysis.BMC pediatrics · 2024Pooled it
- Outcomes with third-party virus-specific T cells after the use of single-antigen cell lines to predict HLA restriction.Blood advances · 2025Trial
- Posoleucel, an Allogeneic, Off-the-Shelf Multivirus-Specific T-Cell Therapy, for the Treatment of Refractory Viral Infections in the Post-HCT Setting.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023Trial
- Role of BK Virus CTLs in the Treatment of BK Virus-Associated Nephropathy in Kidney-Transplant and Hematopoietic Cell Transplant Recipients.Transplant infectious disease : an official journal of the Transplantation SocietyTrial
- Pilot study of early BK polyomavirus in the urine and risk of hemorrhagic cystitis after allogeneic hematopoietic cell transplantation.Cytotherapy · 2026Article
- Case Report: BKV-specific T cells: a fast, safe and potentially effective treatment option for refractory BKV infections in pediatric patients after allogeneic stem cell transplantation.Frontiers in pediatrics · 2026Article
- Adoptive T-cell therapy for virus-associated diseases.Clinical microbiology reviews · 2025Review
- Harnessing virus-specific T cells: expanding therapeutic strategies across diverse populations.Blood advances · 2025Review
- Cellular Therapies in Transplantation - Regulatory T Cell Therapies and Virus Specific Therapies.Current transplantation reports · 2025Article
- Updates in the Diagnosis and Treatment of BK Viraemia in Kidney Transplant Recipients: Current and Future Insights.Journal of clinical medicine · 2025Review
- Review
- CRISPR-based assays for the detection of BK virus and JC virus infections post-kidney transplantation.Military Medical Research · 2025Article
- BK Virus-Specific T Cell Response Associated with HLA Genotypes, RhD Status, and CMV or EBV Serostatus in Healthy Donors for Optimized Cell Therapy.Journal of clinical immunology · 2025Article
- A Phase I Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against BK-Virus in Adult Kidney Transplant Recipients.Journal of medical virology · 2025Article
- [BK virus nephropathy after allogeneic hematopoietic stem cell transplantation: a case report and literature review].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025Review
- Review
- Donor HLA-DQ genetic and functional divergence affect the control of BK polyoma virus infection after kidney transplantation.Science advances · 2025Article
- Virus-Specific T-Cell Therapy for the Management of Viral Infections in the Immunocompromised.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2025Review
- Compassionate access to virus-specific T cells for adoptive immunotherapy over 15 years.Nature communications · 2024Article
- Review
Corrections and comments
- Erratum issued
Authors and funding
43 authors at 1 institution in 1 country.
Funding
Abstract
purposeBK virus-associated hemorrhagic cystitis (BKV-HC) is a common complication of allogenic hematopoietic stem cell transplantation (AHSCT), particularly in recipients of alternative donor transplants, which are being performed in increasing numbers. BKV-HC typically results in painful hematuria, urinary obstruction, and renal dysfunction, without a definitive therapeutic option.
methodsWe performed a clinical trial (ClinicalTrials.gov identifier: NCT02479698) to assess the feasibility, safety, and efficacy of administering most closely HLA-matched third-party BKV-specific cytotoxic T lymphocytes (CTLs), generated from 26 healthy donors and banked for off-the-shelf use. The cells were infused into 59 patients who developed BKV-HC following AHSCT. Comprehensive clinical assessments and correlative studies were performed.
resultsResponse to BKV-CTL infusion was rapid; the day 14 overall response rate was 67.7% (40 of 59 evaluable patients), which increased to 81.6% among evaluable patients at day 45 (40 of 49 evaluable patients). No patient lost a previously achieved response. There were no cases of de novo grade 3 or 4 graft-versus-host disease, graft failure, or infusion-related toxicities. BKV-CTLs were identified in patient blood samples up to 3 months postinfusion and their in vivo expansion predicted for clinical response. A matched-pair analysis revealed that, compared with standard of care, after accounting for prognostic covariate effects, treatment with BKV-CTLs resulted in higher probabilities of response at all follow-up timepoints as well as significantly lower transfusion requirement.
conclusionOff-the-shelf BKV-CTLs are a safe and effective therapy for the management of patients with BKV-HC after AHSCT.
Indexed as
Identifiers
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.