Health

Cellular Immunotherapy for Viral Induced Cancer / EBV Positive Lymphomas

Study Overview

This clinical study explores the effectiveness of autologous Epstein–Barr virus (EBV)-specific T cell therapy in treating patients with EBV-positive lymphoid malignancies who have not responded to first-line treatments. The targeted conditions include:

  • Diffuse Large B-Cell Lymphoma
  • Hodgkin Lymphoma
  • Post-Transplant Lymphoproliferative Disease

These diseases are associated with the Epstein-Barr Virus, a common virus that can contribute to the development of certain cancers, particularly in immunocompromised individuals.

The study focuses on patients whose disease has relapsed or progressed despite standard therapies, offering a novel immunotherapeutic approach that uses the patient’s own immune cells to target EBV-infected tumor cells.

Scientific Rationale

EBV-specific T cell therapy is a form of personalized immunotherapy. It involves isolating and expanding T cells from the patient that specifically recognize EBV-infected cells, then reinfusing them to enhance the body’s immune response against cancer.

This approach is particularly promising for EBV-driven malignancies, where viral antigens provide a clear target for immune-based therapies.

Participation Eligibility

Eligibility for participation depends on several clinical and demographic factors. Each clinical trial follows strict inclusion and exclusion criteria to ensure patient safety and the integrity of results.

General Considerations

Eligibility may include:

  • Age and gender
  • Disease type and stage
  • Prior treatments
  • Overall health status

Meeting eligibility criteria does not guarantee enrollment. Interested individuals should contact the study team for further evaluation.

Inclusion Criteria

Participants must meet the following requirements:

Disease-Specific Cohorts

The study includes three primary cohorts:

  • Cohort A (DLBCL):
    • Relapsed disease (first or subsequent relapse) not eligible for autologous transplantation after salvage therapy, or
    • Relapse following autologous transplantation
  • Cohort B (Hodgkin Lymphoma):
    • Failure of or intolerance to Brentuximab Vedotin
  • Cohort C (PTLD):
    • Failure of Rituximab treatment

Additional Requirements

  • Evidence of active lymphoma or PTLD within the past 3 months (via imaging)
  • Tumor positivity for EBV-encoded RNA (EBER) confirmed by a certified laboratory
  • Absolute lymphocyte count (ALC) > 500/µL
  • Age ≥ 12 years
  • Body weight ≥ 35 kg
  • Performance status:
    • ECOG score 0–2, or
    • Lansky score ≥ 60 (for pediatric patients)
  • Ability to understand and comply with study procedures
  • Provision of informed consent (or assent for minors)

Exclusion Criteria

Participants will be excluded if any of the following conditions apply:

  • Known central nervous system lymphoma
  • Primary refractory HL or DLBCL
  • Bulky disease
  • Prior relapse after EBV-specific T cell therapy
  • Recent use of high-dose corticosteroids
  • Positive tests for infectious diseases including:
    • HIV
    • Hepatitis B or C
    • Syphilis
    • Human T-cell leukemia virus (HTLV)
  • Pregnancy or breastfeeding
  • Uncontrolled systemic infections
  • Prior allogeneic hematopoietic stem cell transplantation
  • Known primary immunodeficiency

Study Locations

The trial is being conducted at participating sites within the Mayo Clinic network. As study availability and recruitment status may change, prospective participants are encouraged to contact the study team directly for the most current information.

Conclusion

This study represents an important advancement in targeted cancer immunotherapy. By leveraging the body’s own immune system to specifically target EBV-associated malignancies, EBV-specific T cell therapy offers a promising treatment avenue for patients with limited options after standard therapies have failed.

Ongoing research will determine its safety, efficacy, and potential role in future oncology practice, particularly for virus-associated lymphomas.

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