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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT06773091

Run by

Shanghai NK Cell Technology Co., LTD

People needed

76

Starts

2025-02-07

Expected to finish

2027-06-01

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntary signing of a written informed consent form.
• Age between 18 and 70 years.
• Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients who are not amenable to surgical resection, with no standard treatment options, or who have relapsed or progressed after standard treatment, or are resistant or intolerant to standard treatment.
• At least one assessable tumor lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected survival ≥12 weeks.
• Must have adequate bone marrow, liver, and renal function.

You may not qualify if…

• Insufficient washout period for prior anti-tumor treatments before the first dose, including chemotherapy, targeted therapy, antibody therapy, and radiotherapy.
• Participation in another clinical trial and use of investigational drugs within 28 days before the first dose.
• Requirement for anticoagulation therapy.
• Symptomatic brain parenchymal metastases with less than 4 weeks of stability after treatment.
• Active pulmonary diseases, including but not limited to interstitial lung disease, pneumonitis.
• Uncontrolled active infections.
• Uncontrollable massive pleural effusion, ascites, or pericardial effusion.
• Previous receipt of other cellular therapies.
• Planned concurrent participation in other anti-tumor treatments during the study.
• Pregnant or breastfeeding women.

Where it is running

• Peking University Cancer Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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