for people ages 21 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Alain Algazi



This study is a multi-center, randomized, open label, Phase III clinical trial for advanced Nasopharyngeal Carcinoma(NPC) Patients. Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's cytotoxic T lymphocytes (CTL) that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T lymphocytes may kill more tumor cells. This Phase III trial is to assess if combined gemcitabine-carboplatin (GC) followed by adoptive T-cell therapy would improve clinical outcome for patients with advanced nasopharyngeal carcinoma (NPC). It is also the world's first, and largest, Phase 3 T-cell therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from 29 hospital centers across Asia and the United States. This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38 patients at the National Cancer Centre, Singapore. This trial produced the best published 2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with advanced NPC who received autologous EBV-specific CTL. Kindly see for the Phase 2 publication titled "Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and/or Locally Recurrent Nasopharyngeal Carcinoma".

Official Title

A Multicentre, Randomized, Open-Label, Phase III Clinical Trial Of Gemcitabine And Carboplatin Followed By Epstein-Barr Virus-Specific Autologous Cytotoxic T Lymphocytes Versus Gemcitabine And Carboplatin As First Line Treatment For Advanced Nasopharyngeal Carcinoma(NPC) Patients


330 patients will be randomized after their eligibility status has been fully determined and informed consent has been obtained. Patients will be randomly allocated to receive either Arm A (Gemcitabine and Carboplatin (GC) x 4 cycles and EBV-specific CTL) or Arm B (GC x 6 cycles alone) in a 1:1 ratio using a stratified block randomization scheme. The stratification variables are country and disease stage (metastatic vs locally recurrent)

After randomization, patients in Arm A will have their peripheral blood taken for the establishment of cytotoxic T cell line and EBV transformed lymphoblastoid cell line (CTL). Within two weeks of enrollment, patients will commence combination GC chemotherapy for a total of 4 cycles. Patients in Stage 2 of study will receive the EBV-specific CTL immunotherapy.


Nasopharyngeal Carcinoma Nasopharyngeal Carcinoma (NPC) NPC immunotherapy Nasopharyngeal Cancer Nose Cancer Cell therapy Head and Neck Cancer Cytotoxic T Lymphocytes chemotherapy Epstein-Barr Virus Carcinoma Nasopharyngeal Neoplasms Gemcitabine Carboplatin autologous EBV specific Cytotoxic T Lymphocytes combination IV gemcitabine and IV carboplatin (AUC2)


For people ages 21 years and up

Key Inclusion Criteria

  1. Metastatic or locally recurrent EBV-positive, non-keratinizing and/ or undifferentiated NPC* who do not have curative options such as chemo-radiation or surgery

*Subjects will be enrolled based on confirmed histology diagnosis of the NPC

  1. Radiologically measurable disease
  2. Human Immunodeficiency Virus (HIV) negative*
  3. Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests available within 12 months before screening or at screening
  4. Bilirubin <2 x upper limit of normal (ULN) and aspartate aminotransferase (AST),alanine aminotransferase (ALT) <3 x ULN
  5. Calculated creatinine clearance (CRCL) ≥40 mL/min. Glomerular Filtration Rate (GFR) is calculated based on Cockcroft-Gault method.
  6. Normal corrected calcium levels
  7. Absolute neutrophil count >1200/mm3, hemoglobin (Hb) ≥10 g/dL and platelets≥100,000/mm3
  8. Male or female
  9. Age ≥21 years
  10. . Eastern Cooperative Oncology Group Performance Scale (ECOG-PS) ≤2
  11. . Written informed consent
  12. . Life expectancy >6 months

Key Exclusion Criteria

  1. Severe concomitant illness i.e. chronic obstructive pulmonary disease (COPD), ischemic heart disease (IHD), active congestive cardiac failure (CCF), active angina pectoris,uncontrolled arrhythmia, uncontrolled hypertension
  2. HIV Positive*
  3. Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests available within 12 months before screening or at screening
  4. Pregnant or lactating females
  5. Refuse of use of contraception during trial (both male and female patients)
  6. Investigational therapy less than one month prior to study entry
  7. Pre-existing peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] ≥2)
  8. Central nervous system metastasis
  9. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis and T1] or any cancer curatively treated >3 years prior to study entry
  10. Positive hepatitis B surface antigen (HBsAg) results
  11. . Known history of hepatitis C and recovery status has not been determined at time of screening
  12. . Prior chemotherapy for metastatic or locally recurrent disease


  • Prior radiotherapy with curative intent
  • Prior chemo-radiotherapy with curative intent
  • Adjuvant chemotherapy
  • Localised palliative radiotherapy Prior chemotherapy must be > 6 months before screening
  • . Severe intercurrent infections
  • . Prior immunotherapy for metastatic or locally recurrent disease


• Adjuvant immunotherapy/ biologics


  • UCSF HDF Comprehensive Cancer Center accepting new patients
    San Francisco California 94143 United States
  • Stanford Cancer Center accepting new patients
    Stanford California 94305 United States


accepting new patients
Start Date
Completion Date
Tessa Therapeutics
Phase 3
Lead Scientist
Alain Algazi
Study Type
Last Updated