Stopped: Phase 1B part was completed with review of DLTs and cumulative safety data by Safety Data Review Committee and identification of a safe RP2D. Post-internal review, sponsor decided to terminate the study, and hence, Phase 2 part was not conducted.
This is a multicenter, open-label, single-arm Phase 1B/2 study to assess the safety and efficacy of tabelecleucel in combination with pembrolizumab for the treatment of subjects with platinum-pretreated, recurrent/metastatic Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC).
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Cohort 1B: Number of Participants With Dose-Limiting Toxicities (DLTs)
Timeframe: From Day 1 through Day 21 of Cycle 1
Cohort 1B: Maximum Tolerated Dose (MTD)
Timeframe: From Day 1 through Day 21 of Cycle 21
Cohort 1B: Recommended Phase 2 Dose (RP2D) of Tabelecleucel in Combination With Pembrolizumab
Timeframe: From Day 1 through Day 21 of Cycle 1
Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
Cohort 2: Characterization of the Safety Profile: Number of Participants With TEAEs and TESAEs
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
Cohort 2: Objective Response Rate (ORR)
Timeframe: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)