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

Recruiting now · Phase 1

Conditions studied: Hematopoietic and Lymphoid Cell Neoplasm, Immunocompromised

In brief

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.

Key facts

Study ID

NCT03425526

Run by

M.D. Anderson Cancer Center

People needed

16

Starts

2018-03-15

Expected to finish

2027-01-01

Last updated by the study team

2026-02-19

Who can join

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

You may qualify if…

• 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.
• Patients age 1 year or older with asymptomatic adenovirus viremia defined as no symptoms of adenovirus disease and EITHER two positive and quantifiable qPCR tests taken one week apart or one single measurement with >/= 1000 copies.
• Patients age 1 year or older with criteria of probable or definitive adenoviral diseases as defined in Appendix A.
• Willingness to comply with the study protocol requirements.

You may not qualify if…

• 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.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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