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Autologous EBV Specific CTLs for Therapy of Severe Chronic EBV Infection

Phase 1
Not Enrolling
Epstein-Barr Virus Infections

Thank you

Trial Information

Autologous EBV Specific CTLs for Therapy of Severe Chronic EBV Infection

Ten to sixty ml (2-12 teaspoons) of blood will be collected from the patient which we use to
grow the T cells. These T cells are then stimulated with EBV infected cells (which have been
treated with radiation so that they cannot grow). This stimulation trains the T cells to
kill EBV infected cells. We then test the T cells to make sure that they kill the EBV
infected cells.

Therapy can take place in one of the specifically designated outpatient clinics so hospital
admission is not required. First, patients will be given doses of Tylenol (for any
aches/pains) and Benadryl (for any minor allergic reactions such as itching/rash). Next,
the T cells will be injected into a vein over a 10 minute period. Patients will be closely
watched for any side effects.

If a patient shows some response to the treatment they may receive up to three additional T
cell injections at three month intervals. Patients will need to be seen every other week in
the clinic for six weeks after the injection. Following that, patients will either be seen
in the clinic or contacted by one of the research staff working on this study, once a month
for one year.

To learn more about the way the T cells are working and how long they last in the body, an
extra 40 mls(8 teaspoonfuls) of blood will be taken at these visits. Additionally, 3 mls
(1/2 teaspoonful) of blood will be taken prior to the infusion and monthly thereafter to
conduct a CBC (a test to look at the components of the blood).

Inclusion Criteria:

- Patients must have severe chronic EBV infection as manifested by 6 months of
symptoms Either elevated peripheral blood EBV DNA (>4000 genomes per ug PBMC DNA) or
free EBV DNA in serum or CSF or VCA antibody titer > 1/640

- Seronegative for HIV

- Not on investigational agents in the last 4 weeks

- Signed informed consent obtained from patient/guardian

- CTLs available

- Performance status; Karnofsky >60

- Creatinine < 3X normal

- Bilirubin < 5X normal

- Normal electrolytes, calcium, phosphorus, nutritional status

- Females with child-bearing potential must utilize effective birth control.

Exclusion Criteria:

- Patients with a severe intercurrent infection

- Patients that recently received high dose steroids within the last week or other
immunosuppressive drugs within a week (or longer as indicated by the half life of the

- Patients with life expectancy of less than 6 weeks

- Pregnant or lactating females

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

to determine the safety of intravenous injections of autologous EBV specific cytotoxic T cell lines in individuals with severe chronic EBV infection

Outcome Time Frame:

1 yr

Safety Issue:


Principal Investigator

Helen E Heslop, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Center for Cell and Gene Therapy, Baylor College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

January 2000

Completion Date:

December 2008

Related Keywords:

  • Epstein-Barr Virus Infections
  • Virus Diseases
  • Epstein-Barr Virus Infections



Texas Children's Hospital Houston, Texas  
The Methodist Hospital Houston, Texas  77030