Constitutive IL7 (C7R) Modified EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma

Description

This study is for patients that have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease which has come back or has not gone away after treatment, including the best treatment the investigators know for these diseases. Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma, suggesting that plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patie

Trial Eligibility

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.

Study Info

Interventions

Locations Recruiting

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