Constitutive IL7 (C7R) Modified EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
Baylor College of Medicine
Summary
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 patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor. The investigators have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses. The investigators think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study the investigators will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. The investigators know that T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion into the body. The investigators have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time. The purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on cancer.
Description
The patient will donate blood in order to make C7R-EBV T cells. Depending on how long ago the cells were generated, they have been frozen. To get the C7R to be made by the T-cell, the investigators inserted a gene into the T-cell. This is done using certain parts of a virus (known as a retrovirus) that can carry the gene into the T cells. Because patients receive cells with a new gene in them, they will befollowed for a total of 15 years to see if there are any long term side effects of gene transfer. When they are enrolled in this study, patients are assigned a dose of C7R EBV T cells. The a…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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 d…
Interventions
- BiologicalDose Level 1A: 2 x 10^7 cells/m2
2 x 10\^7 cells/m2
- BiologicalDose Level 2A: 6 x 10^7 cells/m2
6 x 10\^7 cells/m2
- BiologicalDose Level 2B: 6 x 10^7 cells/m2
6 x 10\^7 cells/m2
- BiologicalDose Level 3B: 2 x 10^8 cells/m2
2 x 10\^8 cells/m2
- BiologicalDose Level 3A: 2 x 10^8 cells/m2
2 x 10\^8 cells/m2
Locations (2)
- Houston Methodist HospitalHouston, Texas
- Texas Children's HospitalHouston, Texas