EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma

Launched by BAYLOR COLLEGE OF MEDICINE · Dec 7, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients who have certain types of lymph gland diseases, specifically Hodgkin and non-Hodgkin lymphoma that is linked to the Epstein-Barr virus (EBV). The researchers are focusing on a type of immune cell called T cells, which can be trained to target and destroy cancer cells infected with EBV. The goal is to see if adding a new gene to these T cells can help them survive longer in the body, potentially improving their ability to fight the cancer.

To participate in this trial, patients must have an EBV-positive lymphoma and have either experienced a relapse or have persistent disease despite previous treatments. Eligible participants include individuals of any age who weigh at least 10 kg and can provide informed consent. Throughout the study, participants will receive the modified T cells and will be monitored to see how long these cells remain in their blood and how they affect the cancer. It’s important to know that individuals who are pregnant, breastfeeding, or have certain infections or health issues may not be eligible for this trial.

Gender

ALL

Eligibility criteria

• • 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.