CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

* 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
* ECOG performance status of 0-1

Exclusion Criteria:

* 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
* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study.

主要终点：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. · From enrollment to the end of treatment at week 10；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%. · From day of enrollment to the end of treatment at week 10
次要终点：Determine the patient survival and recurrence rate post-treatment

• Concurrent and adjuvant allogeneic NK cell therapy · EXPERIMENTAL · Participants will receive standard chemoradiotherapy for locally advanced nasopharyngeal carcinoma along with adjuvant therapy of NK cells. Nk cells would be enriched and expanded using PBMCs from healthy donors. Phase 1 dose escalation study which uses 5 different dosages of 0.5 x 10\^7, 0.8x10\^7, 1.1x10\^7, 1.4 x 10\^7, and 1.8x10\^7 to determine the Maximum tolerated dose (MTD). If the MTD is determined in phase 1, the study will enter phase 2, where the determined dose level will be used for participants. The participants will receive six intravenous NK cell infusions at weeks 3,6,7,8,9, and 10 during and after CRT. If the participant's EBV level is still detectable, they would be suggested for supplementary NK cell treatments for an additional four weeks.

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.