Clinical trial · Interventional
Integrating Allogeneic NK Cells in High-risk Advanced Stage III-IV Nasopharyngeal Cancer Patients
Phase 1/2 Trial Integrating Allogeneic NK Cells in High-risk Advanced Stage III-IV Nasopharyngeal Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Maximum Tolerated Dose | — | UNRESOLVED | — |
| Minimal Residual Disease | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma (NPC) | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Recurrent Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogenic expanded Natural Killer Cells (AlloNK1) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Concurrent and adjuvant allogeneic NK cell therapy
- description
- 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.
- interventionNames
- Biological: Allogenic expanded Natural Killer Cells (AlloNK1)
Primary outcomes (2)
- measure
- Determine the MTD of allogenic NK cells
- timeFrame
- From enrollment to the end of treatment at week 10
- description
- The primary objective of this trial is to determine the MTD of allogeneic NK cells when used with concurrent CRT in advanced NPC patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (16)
- RESULTGoodman SN, Zahurak ML, Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med. 1995 Jun 15;14(11):1149-61. doi: 10.1002/sim.4780141102. PMID 7667557
- RESULTCheung, Y.K., Dose FInding by the Continual Reassessment Method. 2011: Chapman & Hall/CRC press.
- RESULTcheung, Y.K., Coherence principles in dose-finding studies. Biometrika, 2005. 92: p. 10.
- RESULTYin, G. and Y. Yuan, Bayesian model averaging continual reassessment method in phase I clinical trials. Journal of the American Statistical Association, 2009. 104(487): p. 954-968.
- RESULTO'Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics. 1990 Mar;46(1):33-48. PMID 2350571
- RESULTJin YY, Yang WZ, Zou S, Sun ZY, Wu CT, Yang ZY. Chemoradiotherapy combined with NK cell transfer in a patient with recurrent and metastatic nasopharyngeal carcinoma inducing long-term tumor control: A case report. Medicine (Baltimore). 2020 Oct 23;99(43):e22785. doi: 10.1097/MD.0000000000022785. PMID 33120792
- RESULTLin M, Luo H, Liang S, Chen J, Liu A, Niu L, Jiang Y. Pembrolizumab plus allogeneic NK cells in advanced non-small cell lung cancer patients. J Clin Invest. 2020 May 1;130(5):2560-2569. doi: 10.1172/JCI132712. PMID 32027620
- RESULTIshikawa T, Okayama T, Sakamoto N, Ideno M, Oka K, Enoki T, Mineno J, Yoshida N, Katada K, Kamada K, Uchiyama K, Handa O, Takagi T, Konishi H, Kokura S, Uno K, Naito Y, Itoh Y. Phase I clinical trial of adoptive transfer of expanded natural killer cells in combination with IgG1 antibody in patients with gastric or colorectal cancer. Int J Cancer. 2018 Jun 15;142(12):2599-2609. doi: 10.1002/ijc.31285. Epub 2018 Feb 14. PMID 29388200