Actively Recruiting

Phase 1
All Genders
NCT03425526

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

Led by M.D. Anderson Cancer Center · Updated on 2026-02-19

16

Participants Needed

1

Research Sites

459 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Immunocompromised patients
  • Patients 1 year of age or older
  • Patients with asymptomatic adenovirus viremia confirmed by two positive qPCR tests one week apart or one measurement with �3e= 1000 copies
  • Patients with probable or definitive adenoviral disease
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study
  • Written informed consent or assent from patient, parent, or guardian
  • Willingness to follow study protocol requirements
  • English and non-English speaking patients
Not Eligible

You will not qualify if you...

  • Receiving prednisone > 0.1 mg/kg/day or equivalent at enrollment
  • Received anti-thymocyte globulin (ATG) within 14 days before enrollment
  • Received donor lymphocyte infusion (DLI) or Campath within 28 days before enrollment
  • Having uncontrolled bacterial infections without at least 72 hours of stable therapy
  • Having uncontrolled fungal infections without at least 1 week of stable antifungal therapy
  • Active acute graft versus host disease (GVHD) grade �3e= 2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

D

David Marin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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