This clinical trial aims to determine whether Natural Killer (NK) cell therapy administered in combination with concurrent chemoradiotherapy (CRT) can reduce recurrence in patients with advanced nasopharyngeal cancer (NPC), and to identify the highest safe and tolerable dose of allogeneic NK cells. Allogeneic NK cells, derived from healthy donors, have demonstrated good tolerability in cancer patients.
The primary research questions are:
1. What is the maximum tolerated dose (MTD) of allogeneic NK cells when administered with CRT in NPC patients? 2. Can the addition of allogeneic NK cells to standard CRT reduce the proportion of NPC patients with detectable plasma EBV-DNA from 30% to 10%?
Phase 1: Participants will receive one of five escalating doses of allogeneic NK cells with CRT to determine the MTD.
Phase 2: Participants will receive the established MTD NK dose together with CRT.
Participants will undergo regular safety monitoring, side-effect assessment, measurement of plasma EBV-DNA levels, and surveillance for disease recurrence.
Diagnosed with NPC Stage III-IVA/B (T1-4, N1-3, M0)
Able to tolerate convectional CRT
Detectable EBV level at diagnosis
Adequate organ function ANC ≥ 1500/µL Platelet count ≥ 100,000/µL Creatinine clearance ≥60ml/minute Total bilirubin ≤ 1.5 x upper limit normal (ULN) AST ≤ 2 x upper limit normal ALT ≤ 2 x upper limit normal
History of Autoimmune Disease or any condition resulting in immunocompromised state (e.g., Drug induced)
ECOG performance status above or equal to 2
Poor Organ Function
Lactating or pregnant
Sequential
Allogenic expanded Natural Killer Cells (AlloNK1)
Biological/VaccineThe NK cells would be enriched and expanded ex vivo in a GMP facility from healthy donor PBMCs. Prior to administration, the NK cells would be formulated in an infusion medium based on the corresponding dose level that is required for each participant. Participants will receive an intravenous infusion of NK cells during and after the standard CRT. Six doses are administered at weeks 3,6,7,8,9, and 10. In Phase 1, NK cell doses range from 0.5x10\^7 to 1.8x10\^7 cells/kg for the determination of the maximum tolerated dose (MTD). In phase 2, all participants will receive NK cells at the established MTD.
Determine the MTD of allogenic NK cells
The primary objective of this trial is to determine the MTD of allogeneic NK cells when used with concurrent CRT in advanced NPC patients.
The percentage of patients with detectable plasma EBV-DNA decreased to 10% post treatment
Primary endpoint is set at the percentage of patients with detectable post-treatment circulating EBV-DNA has decreased from 30% to 10%.
Determine the patient survival and recurrence rate post-treatment
Secondary endpoint is in determining the change in patient survival and recurrence rate within 24-36 months post-treatment under this new treatment regimen when compare with historic cohorts under standard treatments
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