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EBV-specific T-cell Therapy for Lymphoma (GRALE)

This study is testing a treatment called EBV-specific T cells (GRALE) for people with Hodgkin's Disease, Non-Hodgkin's Lymphoma, Lymphoproliferative Disease, or Lymphoma that is linked to the Epstein-Barr virus (EBV). EBV is a common virus that can cause "mono" and is found in some lymphoma cells. The EBV-specific T cells are designed to help your body's immune system find and fight these cancer cells. You may also receive standard chemotherapy medicines, cyclophosphamide and fludarabine, before the T cells. Researchers will be looking to see if this treatment is safe and what dose works best. This study is for patients whose lymphoma has come back, is at risk of coming back, or hasn't gone away after other treatments.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 136 participants.
What's involved
You would give blood to create the EBV-specific T cells. You may receive chemotherapy over three days, followed by two doses of GRALE T cells given two weeks apart. Additional doses may be given if your lymphoma shows improvement.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow up with you in the clinic or by phone yearly for 5 years after the injections.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01555892

Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE

Recruiting
PHASE1All AgesInterventionalTreatment
Baylor College of Medicine
~136 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:EBV-specific T cells: AEBV-specific T cells: B

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of toxicity of escalating doses of LMP, BARF1 and EBNA1 T lymphocytes
Measured over 8 weeks

Conditions

Hodgkin's Disease
Non-Hodgkin's Lymphoma
Lymphoproliferative Disease
Lymphoma

Explore related trials

Chronic Active EBV DiseaseHodgkin's GranulomaNon-Hodgkin LymphomaT/NK-lymphoproliferative diseaseX-linked Lymphoproliferative Syndrome 1

Where it's being run

3 sites across 1 states
Texas3

Study leadership

  • Helen E Heslop, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Helen E Heslop, MD
[email protected]
832-824-4662
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

CAEBV is defined as patients with high EBV viral load in plasma or PBMC (\> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
Patients with relapsed or refractory lymphoma that are eligible for a stem cell transplant will not be treated on this study as an alternative to transplant.

What this trial measures

  • Assessment of toxicity of escalating doses of LMP, BARF1 and EBNA1 T lymphocytes8 weeks

    To determine the safety of escalating doses of 2 intravenous injections of autologous or syngeneic rapid LMP, BARF1 and EBNA1 specific T-lymphocytes (VSTs) in patients with EBV-associated Hodgkin's Disease or non-Hodgkin's lymphoma or T/NK-lymphoproliferative disease and CAEBV.