Baylor College of Medicine

MABEL Study (H-35253)

Description

Content

Administration of Most Closely Matched Third Party Rapidly Generated LMP, BARF1, and EBNA1 Specific Cytotoxic T-Lymphocytes to Patients with EBV-Positive Lymphoma and Other EBV-Positive Malignancies (MABEL)

Age Requirement: 0 to 65+

The subject has a type of lymph gland disease called Hodgkin disease (HD) or non-Hodgkin lymphoma (NHL), T/NK-lymphoproliferative disease or severe chronic active Epstein Barr virus (CAEBV) which has come back, is at risk of coming back, or has not gone away after treatment, including the best treatment we know for these diseases. This research study uses special immune system cells called LMP, BARF-1 and EBNA1- specific cytotoxic T lymphocytes (MABEL CTLs).

Some patients with lymphoma, T/NK-lymphoproliferative disease, or CAEBV show signs of a virus called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono" or the "kissing disease") before or at the time of their diagnosis. EBV is found in cancer cells of up to half the patients with HD and NHL, suggesting that it may play a role in causing lymphoma. The cancer cells (in lymphoma) and some immune system cells (in CAEBV) infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells (MABEL CTLs) that have been trained to kill EBV infected cells can survive in your blood and affect the tumor.

In previous studies, EBV CTLs were generated from the blood of the patient, which was often difficult if the patient had recently received chemotherapy. Also, it took up to one to two months to make the cells, which is not practical when a patient needs treatment more urgently. To address these issues, the T cells in the current study were made in the laboratory in a simpler, faster and safer way. The T cells we have made will still see LMP proteins but also two other EBV proteins called EBNA-1 and BARF. These cells are called MABEL CTLs. In order to ensure these cells are available for use in patients in urgent clinical need, we have generated MABEL CTLs from the blood of healthy donors and created a bank of these cells, which are frozen until ready for use. We have previously successfully used frozen T cells from healthy donors to treat EBV lymphoma and virus infections and we now have improved our production method to make it faster.

In this study, we want to find out if we can use banked MABEL CTLs to treat HD or NHL, T/NK-lymphoproliferative disease and severe chronic active Epstein Barr Virus (CAEBV). We will search the bank to find a MABEL CTL line that is a partial match with the subject.

NCT#/ClinicalTrials.gov ID: NCT02287311

More about this clinical trial

Contact

David Allen

Phone 1: 832–844–4391

IRB: H-35253

Status:

Active

Created:

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