This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.
Additional locations may be listed on ClinicalTrials.gov for NCT02479698.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Amanda L. Olson
Phone: 713-745-3219
PRIMARY OBJECTIVE:
I. To assess the efficacy, feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched BK specific cytotoxic T lymphocyte (CTL) lines (BK-CTLs) generated by ex vivo expansion to mediate antiviral activity in immunocompromised patients, patients with any type of malignancies, and/or human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDs), and/or history of solid organ transplant with BK and JC infections, and/or Merkel polyoma-virus related Merkel cell tumor(s) and/or polyomavirus.
SECONDARY OBJECTIVE:
I. To assess the persistence of the administered BK-CTLs generated by ex vivo expansion in immunocompromised patients, patients with any type of malignancies, or HIV/AIDs, and/or history of solid organ transplant with BK and JC infections, and/or Merkel polyoma-virus related Merkel cell tumor(s) and/or polyomavirus.
OUTLINE:
Patients receive allogeneic BK-specific cytotoxic T-lymphocytes intravenously (IV) over 30 minutes. Patients achieving partial response, stable disease, or progressive disease are eligible for 19 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy. Patients who do not achieve response after the first CTL infusion may receive pembrolizumab IV over 30 minutes once every 4-6 weeks at the discretion of the principal investigator.
After completion of study treatment, patients are followed up periodically for 12 months.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorAmanda L. Olson