Integrating Allogeneic NK Cells in High-risk Advanced Stage III-IV Nasopharyngeal Cancer Patients

NCT07247201 | Not Yet Recruiting Phase 1 DMC

• 3 other identifiers: 2024-2264CSAINV22jul-0014CTGIIT23jul-0003
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.What is the maximum tolerated dose (MTD) of allogeneic NK cells when administered with CRT in NPC patients?
2. 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%?

Conditions

Nasopharyngeal Carcinoma (NPC); Minimal Residual Disease; Recurrent Nasopharyngeal Carcinoma; Maximum Tolerated Dose

Keywords

Advanced Nasopharyngeal Cancer; Epstein-Barr Virus DNA; Allogeneic NK Cells; Maximum Tolerated Dose

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Determine the patient survival and recurrence rate post-treatment

  24 to 36 months after the last treatment done at week 10

Study Arms (1)

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.

Biological: Allogenic expanded Natural Killer Cells (AlloNK1)

Interventions

Allogenic expanded Natural Killer Cells (AlloNK1) BIOLOGICAL

The 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.

Concurrent and adjuvant allogeneic NK cell therapy

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

Related Publications (16)

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MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lim Chwee Ming

CONTACT

+65 63265978; lim.chwee.ming@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 25, 2025
• Study Start: April 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)