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

Queensland Institute of Medical Research

Status and phase: Completed; Phase 1

Conditions: Lymphoma

Treatments: Biological: Autologous AdE1- Latent Membrane Protein CTLs

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00779337

QIMR P1167

ANZCTR12608000521325

Details and patient eligibility

About

This trial will use a new method of treating lymphoma using a therapy derived from a person's Killer T cells. These Killer T cells are taken from a person's blood and grown in a test tube to increase the number of these cells that are specifically active against the lymphoma cells. The cells are then given to the patient by intravenous infusion with the aim of killing the lymphoma cells. Potentially this treatment will help to kill the residual/recurrent tumour that is present after other lymphoma treatment and reduce the chance of the tumour recurring.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 therapy
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

Single group study

Experimental group

Description:

Autologous AdE1- Latent Membrane Protein (LMP) Cytotoxic T Lymphocytes.

Treatment:

Biological: Autologous AdE1- Latent Membrane Protein CTLs