Using EBV-specific T cells to treat EBV-positive lymphomas

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 EBV-positive Hodgkin and non-Hodgkin lymphoma, as well as T/NK-lymphoproliferative diseases that have not responded to previous treatments. Participants will donate blood to create genetically modified T cells that target the Epstein-Barr virus (EBV) present in their cancer cells. The trial involves administering these modified T cells, potentially alongside standard chemotherapy, to evaluate their effectiveness and monitor for long-term side effects over a period of 15 years.

Why it matters

Who can join: the full rules

1. 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 who may subsequently be eligible for the treatment component
   2. EBV positive tumor (can be pending)
   3. Weighs at least 10 kg
   4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given a copy of informed consent.
2. INCLUSION CRITERIA AT TIME OF INFUSION

   1\) Any patient regardless of age or sex, with diagnosis of either
   1. EBV positive Hodgkin's lymphoma
   2. EBV positive non-Hodgkin's Lymphoma (regardless of histologic subtype)
   3. EBV (associated)-T/NK-lymphoproliferative disease

   AND either

   A) In first or subsequent relapse or with persistent active disease despite therapy; OR

   B) With active disease if immunosuppressive chemotherapy is contraindicated as determined by the study PI, in consultation with the primary provider as needed, e.g. patients who develop Hodgkin's disease after solid organ transplantation or if the lymphoma is a second malignancy, e.g. a Richter's transformation of CLL.

   2\) EBV positive tumor confirmed by pathology

   3\) Patients with life expectancy ≥ 6 weeks

   4\) Patients with bilirubin ≤ 3x upper limit of normal, AST ≤ 3x upper limit of normal, creatinine ≤ 2x upper limit of normal for age and Hgb ≥ 7.0 (may be a transfused value)

   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.

   7\) Patients with a Karnofsky/Lansky score of ≥ 50

   8\) Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given a copy of informed consent.
3. EXCLUSION CRITERIA AT TIME OF PROCUREMENT

   1\. Known pregnancy or actively breastfeeding (pregnancy test is not required at the time of procurement).
4. EXCLUSION CRITERIA AT TIME OF INFUSION

   1. Pregnant or breastfeeding
   2. Active and uncontrolled bacterial, viral or fungal infection
   3. Current use of systemic corticosteroids (prednisone equivalent \>0.5 mg/kg/day)
   4. Bulky disease resulting in airway obstruction or risk for airway obstruction with further enlargement.

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting
• Harris Health System - Ben Taub General Hospital/Smith Clinic
  Houston, Texas, United States Not yet recruiting
• Texas Children's Hospital
  Houston, Texas, United States Not yet recruiting
• Baylor St. Luke's Medical Center
  Houston, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Bilal Omer, MD — Baylor College of Medicine
• Study coordinator: Bilal Omer, MD
• Email: bomer@bcm.edu
• Phone: 832-824-6855

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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.