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RECRUITING
NCT06773091
PHASE1

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

Sponsor: Shanghai NK Cell Technology Co., LTD

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2025-02-07

Completion Date

2027-06

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

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.

Locations (1)

Peking University Cancer Hospital

Beijing, China