Recruiting
Phase 1

Donor T Cell Therapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03425526

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Immunocompromised

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes

Study Details

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 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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Immunocompromised

Study ID

NCT03425526

Start date

Mar 15, 2018

Status verified date

Sep, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (allogeneic adenovirus-specific CTLs)

Within two weeks of enrollment, patients receive allogeneic adenovirus-specific CTLs 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.

Interventions

Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes

Given IV

Primary outcome measure

  • Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 [ Time Frame: Up to 1 year ]
  • Assessment of response to allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

David Marin, MD

713-792-8750dmarin@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

David Marin

713-792-8750

Principal Investigator:

David Marin

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-09-04.