Status:
RECRUITING
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Immunocompromised
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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 s...
Detailed Description
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 ther...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03425526
Start Date
March 15 2018
End Date
January 1 2027
Last Update
August 14 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030