Evidence map›Paper›PMID 36373249›Full record

Trial reportHaematologica2023

Allogeneic, off-the-shelf, SARS-CoV-2-specific T cells (ALVR109) for the treatment of COVID-19 in high-risk patients.

Spyridoula Vasileiou, LaQuisa Hill, Manik Kuvalekar, Aster G Workineh, Ayumi Watanabe, Yovana Velazquez, Suhasini Lulla, Kimberly Mooney, Natalia Lapteva, Bambi J Grilley and 8 more

5 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in Haematologica, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT04401410 phase1terminatednot on this map

BAT IT: Banked Anti-SARS Cov-2 T Cell Infusions for Treatment of COVID 19

TypeinterventionalSponsorBaylor College of MedicineRan2020 to 2021Enrolled4ConditionsSARS-CoV 2, Viral Infection, COVID 19ArmsDose Finding Phase (MTD), Partially HLA-matched SARS-CoVSTs, Routine care (no SARS-CoVSTs)
NCT07638332 phase1 / phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Single-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation in Children, Adolescents, and Adults

TypeinterventionalSponsorLucasBioRan2026 to 2028Enrolled42ConditionsHemorrhagic CystitisArmsLB-DTK-BKV, Standard-of-care
NCT07670468 phase1 / phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Single-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.

TypeinterventionalSponsorLucasBioRan2025 to 2027Enrolled27ConditionsBKV Infection, EBV Infection, CMV InfectionArmsLB-DTK-MV
NCT07679412 narecruitingnot on this mapstarted 2026, after this paper: background citation

An Exploratory Clinical Study of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.

TypeinterventionalSponsorLucasBioRan2026 to 2027Enrolled5ConditionsCMV RetinitisArmsLB-DTK-CMV
NCT07685457 narecruitingnot on this mapstarted 2026, after this paper: background citation

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.

TypeinterventionalSponsorLucasBioRan2026 to 2027Enrolled6ConditionsBKV Infection, CMV Infection, EBV InfectionArmsLB-DTK-MV
3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Trial
  2. Article
  3. Cytotoxic CD4Signal transduction and targeted therapy · 2026
    Review
  4. Adoptive T-cell therapy for virus-associated diseases.Clinical microbiology reviews · 2025
    Review
  5. Article
  6. 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 · 2025
    Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Therapy With Allogeneic Severe Acute Respiratory Syndrome Coronavirus-2-Specific T Cells for Persistent Coronavirus Disease 2019 in Immunocompromised Patients.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  14. Article
  15. Terrific cells for SARS-CoV-2.Haematologica · 2023
    Article
  16. Article
  17. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Spyridoula VasileiouCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX. sxvasile@texaschildrens.org.
LaQuisa HillCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Manik KuvalekarCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Aster G WorkinehCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Ayumi WatanabeCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Yovana VelazquezCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Suhasini LullaCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Kimberly MooneyCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Natalia LaptevaCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Bambi J GrilleyCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Helen E HeslopCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Cliona M RooneyCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Malcolm K BrennerCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Todd N EagarCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
George CarrumCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Kevin A GrimesCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Ann M LeenCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.
Premal LullaCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and Houston Methodist Hospital, Houston, TX.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Defects in T-cell immunity to SARS-CoV-2 have been linked to an increased risk of severe COVID-19 (even after vaccination), persistent viral shedding and the emergence of more virulent viral variants. To address this T-cell deficit, we sought to prepare and cryopreserve banks of virus-specific T cells, which would be available as a partially HLA-matched, off-the-shelf product for immediate therapeutic use. By interrogating the peripheral blood of healthy convalescent donors, we identified immunodominant and protective T-cell target antigens, and generated and characterized polyclonal virus-specific T-cell lines with activity against multiple clinically important SARS-CoV-2 variants (including 'delta' and 'omicron'). The feasibility of making and safely utilizing such virus-specific T cells clinically was assessed by administering partially HLA-matched, third-party, cryopreserved SARS-CoV-2-specific T cells (ALVR109) in combination with other antiviral agents to four individuals who were hospitalized with COVID-19. This study establishes the feasibility of preparing and delivering off-the-shelf, SARS-CoV-2-directed, virus-specific T cells to patients with COVID-19 and supports the clinical use of these products outside of the profoundly immune compromised setting (ClinicalTrials.gov number, NCT04401410).

Indexed as

COVID-19Hematopoietic Stem Cell TransplantationHumansLymphocytesSARS-CoV-2

Identifiers

PMID36373249
PMCPMC10316279

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.