Using donor T cells to treat immunocompromised patients with adenovirus infections
Administration of Off-the-Shelf, Expanded, Most Closely HLA Matched, Third Party Adenovirus Specific T Cells for Therapy of Adenovirus Related Disease in Immunocompromised Patients
This study is testing whether using donated T cells can help immunocompromised patients fight off adenovirus infections.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03425526 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the safety and feasibility of using allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) to treat immunocompromised patients suffering from adenovirus-related diseases. The CTLs are derived from donated blood cells and are designed to target and eliminate adenovirus infections. Patients will receive these T cells intravenously, with the possibility of additional infusions if necessary. The study will also monitor the persistence of these cells in the patients over a follow-up period of 12 months.
Who should consider this trial
Good fit: Ideal candidates include immunocompromised individuals aged 1 year or older with asymptomatic adenovirus viremia or confirmed adenovirus-related diseases.
Not a fit: Patients currently receiving high doses of prednisone or equivalent immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel treatment option for immunocompromised patients facing severe adenovirus infections.
How similar studies have performed: Other studies utilizing T cell therapies for viral infections have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David Marin — M.D. Anderson Cancer Center
- Study coordinator: David Marin, MD
- Email: dmarin@mdanderson.org
- Phone: 713-792-8750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.