Using special T cells to treat EBV-positive lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on patients with Hodgkin's or non-Hodgkin lymphoma that is associated with the Epstein-Barr virus (EBV). Participants will have their blood drawn to create EBV-specific T cells, known as GRALE T cells, which are then injected back into the patient to target and destroy cancer cells infected by EBV. The treatment involves an initial two doses of GRALE T cells, with the possibility of additional doses if the lymphoma shows a reduction in size after the initial infusions. Patients will be monitored for up to five years to assess the effectiveness and safety of the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria at time of Procurement

1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV) who may subsequently be eligible for the treatment component
2. EBV positive tumor (can be pending at this time)
3. Weighs at least 12kg
4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

Inclusion Criteria at time of Infusion

1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma (regardless of histologic subtype), or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV)\* and

   In second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiply relapsed patients in remission who have a high risk of relapse)\*\* OR any patient with primary disease or in first remission if immunosuppressive chemotherapy is contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group A)

   OR

   In remission or with minimal residual disease status after autologous or syngeneic SCT. (Group B)
2. EBV positive tumor
3. Patients with bilirubin less than or equal to 3x upper limit of normal, AST less than or equal 5x upper limit of normal, and hemoglobin greater than or equal to 7.0 (may be a transfused value).
4. Patients with a creatinine less than or equal to 2x upper limit of normal for age
5. Pulse oximetry of \> 90% on room air
6. Patients should have been off other investigational therapy for 4 weeks prior to entry in this study. PD1/PDL inhibitors will be allowed if medically indicated.
7. Patients with a Karnofsky/Lansky score of greater than or equal to 50
8. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded.
9. Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given copy of informed consent.

   * 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.

Exclusion Criteria at Time of Procurement

1\. Active infection with HIV, HTLV, HBV, HCV (can be pending at this time)

Exclusion Criteria at Time of Infusion

1. Pregnant or lactating
2. Severe intercurrent infection.
3. Current use of systemic corticosteroids \> 0.5 mg/kg/day

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting
• Texas Children's Hospital
  Houston, Texas, United States Recruiting
• Harris Health System (includes ben Taub General Hospital and Smith)
  Houston, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Helen E Heslop, MD — Baylor College of Medicine
• Study coordinator: Helen E Heslop, MD
• Email: hheslop@bcm.edu
• Phone: 832-824-4662

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.