This phase II trial studies how well Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes (CTLs) work in treating patients with EBV lymphomas or other EBV-associated cancers. EBV-CTLs are special immune cells that may attack abnormal cells. EBV-CTLs are made by taking cells from a healthy person, growing them in a laboratory for several weeks to educate them to recognize and destroy EBV infected cells, and then storing them in a freezer until they are required for treatment. This study may help doctors learn more about responses to treatment and any side effects that may occur in patients treated with EBV-CTLs.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03988582.
PRIMARY OBJECTIVE:
I. To determine the overall response rate of adoptive immunotherapy with allogeneic Epstein-Barr virus-specific cytotoxic T-lymphocytes (EBV-specific cytotoxic T cells) derived from HLA haplotype or better matched related or unrelated donors in the treatment of EBV lymphomas or other EBV-associated malignancies.
SECONDARY OBJECTIVES:
I. Define the in vivo expansion of donor populations of EBV-specific cytotoxic T cells.
II. Define kinetics and duration of response in cohorts of patients. Correlate these findings with baseline immune status.
III. In patients treated with cells from donors disparate to their own hematopoietic system evaluate the capacity of the recipient to generate allospecific anti-donor responses.
IV. Evaluate the treatment related mortality (TRM), acute and chronic graft-versus-host disease (GvHD) rates.
OUTLINE:
Patients receive EBV-CTLs intravenously (IV) on days 1, 8, and 15. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up to 2 years.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorSusan Prockop
