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

NCT07247201 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-03-30

No results posted yet for this study

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. 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

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

Interventions

BIOLOGICAL

Allogenic expanded Natural Killer Cells (AlloNK1)

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.

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-04-30
Completion
2026-09-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07247201 on ClinicalTrials.gov