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

NCT06773091 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Shanghai NK Cell Technology Co., LTD

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-07
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06773091 on ClinicalTrials.gov