NCT06773091

A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors

An Open-Label, Single-Arm, Multicenter Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of NK042 Cell Injection (Universal NKR+NK) in Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Shanghai NK Cell Technology Co., LTD · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, multi-center phase 1 clinical study designed to evaluate the safety and preliminary efficacy of NK042 cell injection in patients with advanced solid tumors.

Detailed description

This study is divided into two phases: Phase Ia and Phase Ib. Dose-Escalation and Expansion: * Phase Ia: This dose-escalation phase involves both single-dose and multiple-dose administrations of NK042 in patients with advanced solid tumors. * Phase Ib: This multiple-dose cohort-expansion phase will focus on solid tumor indications that demonstrated preliminary efficacy in Phase Ia.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	NK042	NK042 is an allogeneic, off-the-shelf cellular therapy derived from healthy donors and enriched with NKR+ NK cells.
DRUG	Fludarabine (FLU)	Fludarabine (FLU) is administered as a lymphodepletion regimen prior to NK042 infusion.
DRUG	Cyclophosphamide (CTX)	Cyclophosphamide (CTX) is administered as a lymphodepletion regimen prior to NK042 infusion.

Timeline

• Start date: 2025-02-07
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-01-14
• Last updated: 2026-04-06

Locations

1 site across 1 country: China