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Donor T Cell Therapy for Adenovirus-Related Disease in Immunocompromised Patients

This study is looking at a treatment called allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) for people with weakened immune systems (immunocompromised) who have adenovirus-related disease. This therapy uses special immune cells from a donor that are grown in a lab to help fight the adenovirus. The main goals are to see if this treatment is safe and what side effects it might cause, and to get an early idea of how well it works. You might be able to join if you are immunocompromised and have adenovirus-related disease. The study aims to enroll 16 participants, but its current status is unclear.

Study design
This is an interventional study with no specified phase, planning to enroll 16 participants. It is designed to assess the safety and effectiveness of the treatment.
What's involved
You would receive allogeneic adenovirus-specific cytotoxic T lymphocytes intravenously over 30 minutes. You might receive more infusions if your doctor thinks it's needed.
Compensation
Not stated in the trial record.
Follow-up
After your treatment, you will be followed for 12 months to monitor your health and the treatment's effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03425526

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

Recruiting
PHASE1All AgesInterventionalTreatment
M.D. Anderson Cancer Center
~16 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0
Measured over Up to 1 year
+1 more outcome measured

Conditions

Hematopoietic and Lymphoid Cell Neoplasm
Immunocompromised

Explore related trials

Adenovirus InfectionHematopoietic and Lymphoid Cell Neoplasm

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • David Marin · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

David Marin, MD
[email protected]
713-792-8750
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0Up to 1 year

    Safety and tolerability will be assessed by laboratory assessments, adverse events, and serious adverse events. Adverse events will be graded by the CTCAE version 4.0. Categorical measures will be summarized using frequencies and percentages while continuous variables will be summarized using means, standard deviations, medians, minimums, and maximums.

  • Assessment of response to allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs)Up to 1 year

    The proportion of patients experiencing response will be computed with associated 95% confidence interval (CI). The 95% exact CI for the feasibility criterion of 50% will extend from 25% to 75% for 16 patients.