Background: Median overall survival (OS) and prognosis in patients with advanced EBV-positive NPC remain poor and treatment options are limited. In a small phase II trial (38 Asian pts), EBV-CTLs following chemotherapy (GC) as a first line setting for pts with metastatic and/or recurrent NPC has shown promising efficacy and acceptable toxicity: median OS and overall progression free survival (PFS) was 29.9 and 7.6 months respectively, with 2-year OS rate of 62.9% (Chia et al., Mol Ther., 2014). A Phase III trial has been initiated to evaluate the antitumor efficacy of GC-CTL versus GC in these pts (NCT02578641). Methods: This multicenter, randomized, open-label, two arm study is ongoing across 30 sites in Malaysia, Singapore, Taiwan, Thailand and USA. Eligible pts have a histologically confirmed metastatic or locally recurrent EBV-positive, non-keratinizing and/or undifferentiated NPC (not amenable to curative treatment with surgery and/or chemoradiation therapy), with measurable disease (RECIST v1.1) at screening, ECOG PS≤2 and NCI CTCAE < 2. Pts with CNS metastasis, autoimmune disease or prior immunotherapy are excluded. Prior chemotherapy or radiation with curative intent is allowed. 330 pts will be randomized 1:1 to receive either four cycles of GC followed by six cycles of EBV-CTLs (Arm A) or six cycles of GC alone (Arm B). Stratification factors include country and disease stage (metastatic versus locally recurrent). Analysis of the primary endpoint is based on the hazard ratio calculated using the Cox Proportional Hazard model. Secondary endpoints include PFS, overall response rate, clinical benefit rate and quality of life. Safety assessments will consist of monitoring and recording all adverse events (graded by NCI CTCAE v 4.0). Results: As of 31 Jan 2018, 226 of the planned 330 pts are enrolled. Conclusions: An Independent Data Monitoring Committee has reviewed the trial on 29 Aug 2017 and concluded that trial accrual continue as planned. Clinical trial information: NCT02578641