Actively Recruiting
A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.
Led by Beijing Geekgene Technology Co., LTD · Updated on 2026-02-17
10
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Beijing Geekgene Technology Co., LTD
Lead Sponsor
T
The First Affiliated Hospital of Nanchang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Single-Center, Open-Label Clinical Study to Evaluate the Safety, Preliminary Efficacy of GK01 Cell Injection in Subjects with Advanced Solid Tumors Refractory or Intolerant to Standard Therapy
CONDITIONS
Official Title
A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign a written informed consent document.
- Age between 18 and 75 years, male or female.
- Confirmed advanced lung cancer or esophageal squamous cell carcinoma by cytology or histopathology.
- Disease refractory or intolerant to standard therapy.
- At least one measurable lesion that has not been irradiated or treated locally.
- At least one measurable lesion remains according to RECIST 1.1 criteria.
- ECOG performance status of 0 or 1.
- Expected survival time longer than 3 months.
- Adequate blood and organ function.
- No contraindications to surgery, bronchoscopy, or percutaneous procedures.
You will not qualify if you...
- History of severe allergy or hypersensitivity to drugs used in this study, including lymphodepleting chemotherapy drugs, radiological contrast agents, or components of GK01.
- Use of any investigational drug or systemic anti-tumor therapy within 28 days before lymphodepleting chemotherapy or within 5 half-lives of the previous drug.
- Major surgery within 28 days before signing consent or planned during the study.
- Toxicities from prior anti-tumor treatments have not recovered to Grade 1 or baseline except alopecia and hyperpigmentation.
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 4 weeks before consent or before first infusion.
- History or active autoimmune disease with risk of recurrence.
- Prior bone marrow or organ transplantation.
- Current or prior interstitial lung disease or pneumonia.
- Active tuberculosis infection within 1 year prior to screening.
- Other primary cancers within 5 years before study treatment.
- Significant cardiovascular disease.
- History of bleeding within 6 months prior to consent.
- Metabolic disorders like diabetes with HbA1c ≥8.5% or other serious organ/systemic diseases.
- Central nervous system metastases, leptomeningeal disease, spinal cord compression, or CNS disorders.
- Vaccination with live/attenuated or inactivated vaccines within 28 days before consent or planned during screening.
- Systemic corticosteroids (≥10 mg/day prednisone equivalent) or other immunosuppressants within 14 days before tissue collection or during study.
- Positive tests for hepatitis B, C, HIV, cytomegalovirus, or syphilis.
- Pregnant or breastfeeding females.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
Research Team
B
BenTong Yu, MD
CONTACT
X
Xu Zhang, PhD
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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