Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
Immunocompromised patients.
English and non-English speaking patients.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov