Most Closely HLA-Matched CTLs for Relapsed Epstein Barr Virus(EBV)-Associated Diseases

Completed · Phase 1

Conditions studied: Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Lymphoproliferative Disorder, Nasopharyngeal Carcinoma, Leiomyosarcoma, Severe Chronic Active EBV (SCAEBV)

In brief

Patients have a type of a lymph node cancer called lymphoma, a tumor of the nasal passages called nasopharyngeal carcinoma (NPC), a tumor of a particular type of muscle called leiomyosarcoma (LMS) or a condition called severe chronic active EBV (SCAEBV) syndrome. The disease has come back, may come back or has not gone away after treatment. This voluntary research study uses special immune system cells called LMP-specific cytotoxic T lymphocytes, a new experimental therapy. Some patients with these diseases show evidence of infection with the virus that causes infectious mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of up to half of the patients with lymphomas, and in some cases of NPC and LMS, suggesting that it may play a role in causing these diseases. Those cancer cells (as well as some B cells in SCAEBV) that are 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, called T cells, that have been trained to kill cells infected by EBV can survive in the blood and affect the tumor. This treatment with specially trained T cells has had activity against these viruses when the cells are made from patients with those diseases (or, after bone marrow transplant, from the patient's transplant donor). However, sometimes it is not possible to grow these cells; other times, it may take 2 to 3 months to make the cells, which may be too long when one has an active tumor. We are therefore asking if subjects would like to participate in this study, which tests if blood cells from a donor that is a partial match with the subject (or the transplant donor) that have been grown in the way described above can survive in the blood and affect the disease. These LMP-specific CTLs are an investigational product not approved by the Food and Drug Administration.

Key facts

Study ID

NCT01447056

Run by

Baylor College of Medicine

People needed

37

Starts

2012-02-01

Expected to finish

2020-01-22

Last updated by the study team

2020-02-07

Who can join

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

You may qualify if…

• SCREENING:
• Any patient, regardless of age or sex, with one or more of the following EBV-positive or associated disorders, regardless of the histological subtype: - Hodgkin lymphoma - Non-Hodgkin lymphoma - Lymphoproliferative disorder - Nasopharyngeal carcinoma - Leiomyosarcoma - Severe chronic active EBV infection syndrome (SCAEBV), defined as high EBV viral load in plasma or PBMC (> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
• Karnofsky/Lansky score 50% or more.
• Informed consent explained to and signed by patient or parent/guardian able to give informed consent and given a copy.
• TREATMENT:
• Any patient, regardless of age or sex, with one or more of the following EBV-positive or associated disorders, regardless of the histological subtype: - Hodgkin lymphoma - Non-Hodgkin lymphoma - Lymphoproliferative disorder - Nasopharyngeal carcinoma - Leiomyosarcoma - Severe chronic active EBV infection syndrome (SCAEBV), defined as high EBV viral load in plasma or PBMC (> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
• The disease needs to be in one of the following stages: - At diagnosis or in first relapse AND the patient is unable to receive conventional chemotherapy for his/her condition. - In second or subsequent relapse. - With residual disease after autologous, syngeneic or allogeneic HSCT.
• Life expectancy 6 weeks or more.
• Tumor tissue is positive for EBV.
• Karnofsky/Lansky score 50% or more.
• Bilirubin less than 3 times higher than the normal limits, AST less than 5 times higher than the normal limits, Hgb greater than 8.0 g/dL and serum creatinine less than 3 times higher than the normal limits.
• Pulse oximetry of greater than 90% on room air.
• If post allogeneic HSCT, patient must not have less than 50% donor chimerism in either peripheral blood or bone marrow.
• Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone at time of treatment.
• Informed consent explained to and signed by patient or parent/guardian able to give informed consent and given a copy.
• Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.

You may not qualify if…

• SCREENING:
• Known HIV positivity.
• TREATMENT:
• Currently receiving any investigational agents or have received any tumor vaccines within previous 4 weeks.
• Active acute grade III-IV graft-versus-host disease.
• Severe intercurrent infection.
• Received alemtuzumab or other anti-T-cell antibody within 28 days.
• HIV seropositivity.
• Pregnancy (due to unknown effects of this therapy on a fetus) or lactation.
• Tumor in a location where enlargement could cause airway obstruction.

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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