drugset / Trial / NCT07247201

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

NCT07247201 ↗

Phase 1/2 Not yet recruiting 31 enrolled Singapore General Hospital
NaSequentialOpen-labelPrevention

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.

Timeline

Start
2026-04
Primary completion
2026-04
Completion
2026-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject AlloNK1 Cell therapy 5e+06 cells/kg Intravenous
Subject AlloNK1 Cell therapy 8e+06 cells/kg Intravenous
Subject AlloNK1 Cell therapy 1.1e+07 cells/kg Intravenous
Subject AlloNK1 Cell therapy 1.4e+07 cells/kg Intravenous
Subject AlloNK1 Cell therapy 1.8e+07 cells/kg Intravenous