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A clinical trial of adoptive T-cell immunotherapy for patients with Epstein-Barr virus-associated nasopharyngeal carcinoma.

Phase I/II open-label clinical trial of autologous Epstein-Barr virus-specific T cell therapy as consolidative treatment following chemotherapy for metastatic EBV-associated nasopharyngeal carcinoma.

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000866707
Enrollment
18
Registered
2013-08-06
Start date
2015-09-16
Completion date
2019-12-23
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is evaluating the effect of using T cell immunotherapy following standard chemotherapy for the treatment of nasopharyngeal cancer (NPC). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with metastatic nasopharyngeal cancer and your clinician is planning to treat you with standard chemotherapy. Trial details All participants in this study will receive standard chemotherapy with gemcitabine and cisplatin according to their clinician’s standard clinical care. Following this, they will undergo the experimental immunotherapy. This involves infusing Epstein-Barr Virus (EBV) specific T-cells intravenously (i.e. directly into the vein) up to 6 times, at fortnightly intervals. Participants will be regularly assessed for up to 38 weeks in order to evaluate their response to treatment, and the safety and tolerability of treatment.

Interventions

EBV-specific T cell adoptive immunotherapy. Patients will be identified prior to completing three cycles of chemotherapy for metastatic or loco-regionally recurrent NPC. Blood for T cell therapy manufacture must be collected prior to the completion of the third cycle of chemotherapy. This is to allow sufficient time to generate the T cell therapy, to ensure that all patients commence T cell infusions within a similar timeframe after the completion of chemotherapy. If a patient has already commen

EBV-specific T cell adoptive immunotherapy. Patients will be identified prior to completing three cycles of chemotherapy for metastatic or loco-regionally recurrent NPC. Blood for T cell therapy manufacture must be collected prior to the completion of the third cycle of chemotherapy. This is to allow sufficient time to generate the T cell therapy, to ensure that all patients commence T cell infusions within a similar timeframe after the completion of chemotherapy. If a patient has already commenced chemotherapy, a venesection will occur at the discretion of the Clinical Investigator, based on the fitness of the participant for the venesection, and the patient’s full blood count . Initially, all patients will receive standard chemotherapy (investigator’s choice) for up to 6 cycles, according to standard clinical practice. Following completion of chemotherapy, the tumour will be imaged according to standard procedures, and the level of tumour control will be determined. Patients who experience disease stabilisation, a partial clinical response or a complete clinical response following chemotherapy will be eligible for T cell infusions. Participants who do not experience tumour control will be withdrawn from the study and will receive further standard therapies prescribed by the treating clinicians .. A dose of 2x10^7/m^2 LMP/EBNA1-specific autologous T cells will be given by intravenous infusion at weeks 2,4,6,8,10 and 12

Sponsors

QIMR Berghofer Medical Research Institute
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age 18 years or above 2 . Histologically proven NPC (non-keratinising or undifferentiated carcinoma) at first diagnosis 3. Provision of Informed consent. Approved hospital interpreters will be used for patients who do not have sufficient understanding of English for informed consent to be obtained without the use of an interpreter. 4. First relapse of NPC; either metastatic disease or loco-regionally recurrence that is not resectable 5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 6. Life expectancy of at least 6 months, as determined by the clinical investigator 7. Adequate haematological and biochemical function 8. Completion of a medical questionnaire 9. Suitable to commence treatment, or currently receiving treatment , for metastatic disease or recurrent loco-regional disease not amenable to surgery

Exclusion criteria

1. EBV negative tumour 2 . Serological evidence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis infection (N.B. Positive serology for HBV indicating previous but cleared infection with HBV is not an exclusion criterion) 3. Significant non-malignant disease (e.g. severe cardiac or respiratory dysfunction) 4.. Psychiatric, addictive or any conditions which may compromise the ability to participate in this trial 5. Inability to provide informed consent, including patients with severe cognitive impairment, intellectual disability or mental illness 6. Prior cancers, except those diagnosed greater than 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5 percent, or successfully treated nonmelanoma skin cancer, or carcinoma in situ of the cervix. 7. Currently receiving immunosuppressive therapy, including corticosteroids. At the discretion of the clinical investigator the patient can receive anti-emetics 8. Pregnant, lactating, or unwilling to use adequate contraception

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026