Nivolumab With Epstein Barr Virus Specific T Cells (EBVSTS), Relapsed/Refractory EBV Positive Lymphoma (PREVALE)

Completed · Phase 1

Conditions studied: NonHodgkin Lymphoma, Lymphoproliferative Disorders, EBV Related Lymphoma, EBV-Related PTLD, Hodgkin Lymphoma, EBV Related Non-Hodgkin's Lymphoma, EBV Related Hodgkin's Lymphoma

In brief

Subjects have a type of a lymph node cancer called Non-Hodgkin's Lymphoma (NHL) or lymphoproliferative disease (LPD), which affects their immunity, blood production, and can involve multiple other organs in the body. Their disease has come back or has not gone away after treatment. The experimental treatment plan consists of an antibody therapy called "Nivolumab" that helps the subjects' T-cells control the tumor, and special immune system cells called EBV-specific cytotoxic T lymphocytes, also a new therapy whose side effects are well studied. Some patients with NHL or LPD are infected with the virus that causes infectious mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their diagnosis. The cancer cells that are infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called T cells, that have been trained to kill cells infected by EBV can survive in the blood and affect the tumor. Investigators have used this sort of therapy to treat a different type of cancer that occurs after bone marrow or solid organ transplant called post-transplant lymphoma with good success. These cells are called EBV-specific cytotoxic T-lymphocytes (EBVSTs), and are effective in treating these diseases. These EBVSTs are experimental and not yet approved by the Food and Drug Administration (FDA). Sometimes it is not possible to grow these cells; or they may not last very long in the body after being given into the vein thereby having only limited time to fight the tumor. With this study, investigators aim to increase the duration of time that the T cells can last in the body and can effectively fight the cancer by using nivolumab. Nivolumab is FDA approved for treatment of other kinds of cancer like lung cancer and a skin cancer called Melanoma. The purpose of this study is to find out if EBVST cells in combination with nivolumab are safe, to learn what the side effects are, and to see whether this therapy may help patients with EBV related lymphoma or LPD.

Key facts

Study ID: NCT02973113
Run by: Baylor College of Medicine
People needed: 8
Starts: 2016-02-16
Expected to finish: 2020-07-11
Last updated by the study team: 2021-07-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

PROCUREMENT Inclusion
Any patient, regardless of age* or sex, with measurable EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, (regardless of the histological subtype)\^ or EBV (associated)- T/NK- or B cell lymphoproliferative disease
The first 3 patients enrolled will be adults. Patients <18 years of age are eligible if those first 3 patients do not experience dose limiting toxicity considered to be primarily related to the EBVST or Nivolumab.
\^ Patients with relapsed or refractory lymphoma who failed or are ineligible for an autologous hematopoietic cell transplantation are also eligible for this study.
EBV positive tumor (can be pending)
Weighs at least 12kg
Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given a copy of informed consent.
Life expectancy of greater than 6 weeks.
TREATMENT Inclusion
Any patient, regardless of age* or sex, with measurable EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, (regardless of the histological subtype)\^ or EBV (associated)-T/NK- or B cell lymphoproliferative disease
The first 3 patients enrolled will be adults. Patients <18 years of age are eligible if those first 3 patients do not experience dose limiting toxicity considered to be primarily related to the EBVST or Nivolumab.
\^ Patients with relapsed or refractory lymphoma who failed or are ineligible for an autologous hematopoietic cell transplantation are also eligible for this study.
And
Hodgkin's lymphoma patients in second relapse or first relapse and refractory to at least two lines of salvage chemotherapy including Brentuximab Vedotin or primary refractory disease after at least two lines therapy or
Non- Hodgkin's lymphoma patients in first relapse and/or refractory to at least one salvage chemotherapy or with primary refractory disease after at least two lines of therapy or in second or subsequent relapse or
T/NK- or B lymphoproliferative disease in first relapse and/or refractory to at least one salvage chemotherapy or with primary refractory disease after at least two lines of therapy or in second or subsequent relapse
EBV positive tumor
Patients with life expectancy >/= 6 weeks.
Patients with bilirubin less than or equal to 3x upper limit of normal
AST less than or equal to 5x upper limit of normal
Hgb more than 8.0 (may be a transfused value).
Patients with a creatinine less than or equal to 2x upper limit of normal for age
Pulse oximetry of more than 90% on room air
Patients should have been off other investigational therapy for 4 weeks prior to entry in this study.
Patients with a Karnofsky/Lansky score of >/= 60

You may not qualify if…

PROCUREMENT Exclusion
Active infection with HIV, HTLV, HBV, HCV (can be pending at this time)
History of solid organ transplant
TREATMENT Exclusion
Pregnant or lactating due to unknown effects of this therapy on a fetus or lactation
Severe active intercurrent infection.
Current use of systemic corticosteroids >0.5 mg/kg/day
Currently receiving any investigational agents or radiotherapy within 4 weeks prior to entering the study.
Patients with central nervous system involvement.
History of allergic reactions attributed to nivolumab or any other checkpoint inhibitors.
Uncontrolled autoimmune disease needing systemic steroids or steroid sparing agents except for hypothyroidism or type I diabetes.
History of solid organ transplant
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Lipase more than 70U/ml

Where it is running

Houston Methodist Hospital — Houston, Texas, United States
Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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