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

NCT ID: NCT00779337

Last Updated: 2012-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-05-31

Brief Summary

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single group study

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

Group Type: EXPERIMENTAL

Autologous AdE1- Latent Membrane Protein CTLs

Intervention Type: BIOLOGICAL

Total dose 20-800 million CTL given in 4 equal doses (5-200 million CTL) given intravenously, at weekly intervals for the first cohort of 10 patients and twice a week for the second cohort of 10 patients.

Interventions

Autologous AdE1- Latent Membrane Protein CTLs

Total dose 20-800 million CTL given in 4 equal doses (5-200 million CTL) given intravenously, at weekly intervals for the first cohort of 10 patients and twice a week for the second cohort of 10 patients.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Atlantic Philanthropies

OTHER

Sponsor Role: collaborator

Australian Department of Industry, Tourism and Resources

INDUSTRY

Sponsor Role: collaborator

British Society for Haematology

OTHER

Sponsor Role: collaborator

National Health and Medical Research Council, Australia

OTHER

Sponsor Role: collaborator

Queensland Institute of Medical Research

OTHER

Sponsor Role: lead

Responsible Party

Maher Gandhi

Immunohaematology Laboratory Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maher K Gandhi, MB CHB PhD

Role: PRINCIPAL_INVESTIGATOR

Queensland Institute of Medical Research

Locations

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

ANZCTR12608000521325

Identifier Type: -

Identifier Source: secondary_id

QIMR P1167

Identifier Type: -

Identifier Source: org_study_id