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Donor T Cell Therapy in Treating Immunocompromised Patients with Adenovirus-Related Disease

Trial Status: Active

This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.

Inclusion Criteria

  • Immunocompromised patients with any hematological malignancies.
  • Written informed consent and/or signed assent from patient, parent or guardian.
  • Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
  • Asymptomatic adenovirus viremia defined as no symptoms of adenovirus disease and EITHER two positive and quantifiable quantitative polymerase chain reaction (qPCR) tests taken one week apart or one single measurement with >= 1000 copies.
  • Patients with criteria of probable or definitive adenoviral diseases.

Exclusion Criteria

  • Patients receiving prednisone > 0.1 mg/kg/day or equivalent at time of enrollment, or who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
  • Patients with other uncontrolled infections: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
  • Active acute graft versus host disease (GVHD) grade >= 2.

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: David Marin
Phone: 713-792-8750

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of asymptomatic adenovirus viremia or adenovirus-related disease in immunocompromised hosts.

SECONDARY OBJECTIVES:

I. To obtain preliminary data about the efficacy of administering most closely HLA-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of adenovirus viremia or adenovirus-related disease.

II. To assess the persistence of the administered cells in the patients.

OUTLINE:

Within two weeks of enrollment, patients receive allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) intravenously (IV) over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 12 months.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
M D Anderson Cancer Center

Principal Investigator
David Marin

  • Primary ID 2017-0350
  • Secondary IDs NCI-2018-00929
  • Clinicaltrials.gov ID NCT03425526