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Epstein-Barr Virus (EBV)-Specific T Cells as Therapy for Relapsed/Refractory EBV-positive Lymphomas

Phase 1
18 Years
Not Enrolling

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Trial Information

Epstein-Barr Virus (EBV)-Specific T Cells as Therapy for Relapsed/Refractory EBV-positive Lymphomas

Inclusion Criteria:

- Informed consent.

- EBV-positive lymphoma as determined by in situ hybridization or equivalent (excluding
Burkitts Lymphoma).

- Age 18 years or older.

- ECOG performance status 1, 2 or 3

- Life expectancy of at least 6 months.

- Measurable disease: either relapsing, partially responsive, refractory or progressive
disease, includes disease detected either by clinical examination, radiographic
evaluation (including CT scans, and at physician's discretion by functional imaging),
or a persistently detectable plasma EBV viral load.

- No chemotherapy / radiotherapy and/or antibody therapy for at least 2 weeks prior to
anticipated date of first infusion.

Exclusion Criteria:

- EBV negative tumour

- Presence of detectable malignant cells in the peripheral circulation by flow
cytometry or morphology

- Serious infection within the past 28 days that has not adequately responded to

- Pregnancy, or unwilling to use adequate contraception

- Serology (taken within 3 months of CTL release date) indicating active HBV or HCV
infection, positive serology for HIV I&II, HTLV1 or syphilis

- Negative serology for EBV

- Psychiatric, addictive or any condition which may compromise the ability to
participate in this trial

Type of Study:


Study Design:

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

Outcome Measure:

Feasibility (generation of autologous clinical grade AdE1-LMP-specific CTL from the blood of EBV-positive lymphoma patients)

Outcome Time Frame:

The investigational product for each participant will be assessed post production. The patient will have blood samples taken prior to and following each infusion, and then at 1, 3, 6 & 12 months following the final infusion.

Safety Issue:


Principal Investigator

Maher K Gandhi, MB CHB PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Queensland Institute of Medical Research


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

QIMR P1167



Start Date:

October 2008

Completion Date:

May 2012

Related Keywords:

  • Lymphoma
  • Epstein-Barr virus
  • lymphoma
  • immunotherapy
  • Lymphoma