Actively Recruiting
A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors
Led by Shanghai NK Cell Technology Co., LTD · Updated on 2026-04-06
76
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent form
- Age between 18 and 70 years
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor not suitable for surgery, without standard treatment options, or relapsed/progressed after or intolerant to standard treatment
- At least one tumor lesion that can be measured according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival of at least 12 weeks
- Adequate bone marrow, liver, and kidney function
You will not qualify if you...
- Insufficient washout period from prior anti-tumor treatments including chemotherapy, targeted therapy, antibody therapy, or radiotherapy before the first study dose
- Participation in another clinical trial or use of investigational drugs within 28 days before first dose
- Need for anticoagulation therapy
- Symptomatic brain metastases with less than 4 weeks of stability after treatment
- Active lung diseases such as interstitial lung disease or pneumonitis
- Uncontrolled active infections
- Uncontrollable large pleural effusion, ascites, or pericardial effusion
- Previous receipt of other cellular therapies
- Planned concurrent anti-tumor treatments during the study
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, China, 100142
Actively Recruiting
Research Team
Y
Yongling Fu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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