Advanced Solid TumorsEarly Phase 1NCT07414316
A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.
A Early Phase 1 study testing GK01 Injection in people with Advanced Solid Tumors, run by Beijing Geekgene Technology Co., LTD at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- GK01 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2026to 12 Feb 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and sign a written informed consent document.
- At the date of signing ICF, 18 ~75 years old, male or female.
- Advanced lung cancer or esophageal squamous cell carcinoma confirmed by cytology or histopathology, failed or intolerant to standard therapy.
- At least one measurable lesion that has not been irradiated or received other local therapies.
- At least one measurable lesion remains (RECIST 1.1 criteria).
- ECOG 0-1 points.
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- Expected survival time more than 3 months.
- Adequate hematologic and organ function.
- No absolute or relative contraindications to surgery, bronchoscopy, or percutaneous procedures.
Who cannot join
- History of severe allergy, or hypersensitivity to any component of the drugs used in this study, including but not limited to lymphodepleting chemotherapy drugs, contrast agents for radiological examinations, and excipients of GK01 (such as dimethyl sulfoxide).
- Any investigational drug or systemic anti-tumor therapy within 28 days prior to the start of lymphodepleting chemotherapy preconditioning, or within 5 half-lives of the previous drug.
- Major surgery within 28 days prior to signing the ICF, or planned during the study period.
- Toxicities from previous anti-tumor therapies have not recovered to ≤ Grade 1 or baseline level (according to NCI-CTCAE version 5.0) at the time of signing the ICF, with the exception of alopecia and hyperpigmentation.
- Any uncontrolled active infection requiring parenteral antibiotic, antiviral, or antifungal therapy within 4 weeks prior to signing the ICF or before the first infusion.
- History of or current active autoimmune disease that has the potential to recur (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or subjects at such risk.
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- Prior history of bone marrow or organ transplantation.
- Concurrent or prior history of interstitial lung disease or interstitial pneumonia.
- History of active tuberculosis infection within 1 year prior to screening (subjects with a history of active tuberculosis infection more than 1 year ago may be enrolled if the investigator confirms there is no current evidence of active tuberculosis).
- History of other primary malignancies within 5 years prior to the initiation of the study treatment.
- Clinically significant cardiovascular disease.
- History of bleeding within 6 months prior to signing the ICF.
- Metabolic disorders, such as diabetes mellitus (with glycated hemoglobin [HbA1c] ≥8.5%), or other non-malignant organ or systemic diseases, or secondary reactions to cancer that may lead to high medical risk and/or uncertainty in survival assessment.
- Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders.
- Live/attenuated or inactivated vaccine within 28 days prior to signing the ICF, or planned administration of a live/attenuated or inactivated vaccine during the screening period.
- Systemic corticosteroid therapy (at a dose equivalent to or greater than 10 mg/day of prednisone) or other immunosuppressive medications within 14 days prior to tissue acquisition or during the study period.
- Hepatitis B surface antigen (HBsAg) positivity; With negative HBsAg positive hepatitis B core antibody (HBcAb) ,and if peripheral blood hepatitis B virus (HBV) DNA positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Both Treponema pallidum-specific and non-specific antibody tests are positive.
- Female subjects who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xu Zhang, PhD contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
BenTong Yu, MD, +86-138 7061 4026, ndyfy02006@ncu.edu.cn
About this study
Official title: A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Subjects With Advanced Solid Tumors.
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
- Advanced Solid Tumors
- Being tested
- GK01 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GK01 InjectionDrug
Autologous tumor-reactive T cells injection
| Study group | Role | What they receive |
|---|---|---|
| Tumor-reactive T cells-GK01 | Experimental | Autologous tumor-reactive T cells injection Receives: Drug: GK01 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Measured: 2 years
Secondary outcomes (9)
Count of TCR copies
T-cell receptor sequencing (TCR-seq) by obtaining the copy number of the target GK02 T-cell receptors (TCRs) in peripheral blood：Cmax、Tmax、AUC0-t、AUC0-inf、λz、T1/2.
Measured: 2 years
Concentration of Cytokines
IL-1β、IL-2、IL-4、IL-6、IL-8、TGF-b1、IFN-γ and TNF-α
Measured: 2 years
Percentage of Lymphocyte subsets
Total T cells、Th/Ti cells、Ts/Tc cells、NK cells
Measured: 2 years
Circulating tumor DNA
The time between Circulating tumor DNA (ctDNA) positivity and Clinical Progression
Measured: 2 years
Objective response rate (ORR)
Proportion of subjects achieving complete response (CR) and partial response (PR)
Measured: 2 years
Progression-free Survival (PFS)
Time from GK01 treatment to disease progression or death
Measured: 2 years
Disease Control Rate (DCR)
Proportion of subjects achieving best response of CR, PR, or SD treated with GK01
Measured: 2 years
Duration of Response (DOR)
Time from first documented evidence of confirmed CR or PR until the first documented evidence of disease progression or death, whichever occurs earlier
Measured: 2 years
Overall survival (OS)
Time from GK01 treatment to death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start13 Feb 2026 (estimated)
- Primary completion12 Feb 2027 (estimated)
- Study completion12 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Geekgene Technology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414316
- Sponsor's protocol ID
- GK01-NCDXIIT01
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Subjects With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT07414316
- Acronym / sponsor ID
- GK01-NCDXIIT01
- Conditions
- Advanced Solid Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Geekgene Technology Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Study start
- 13 Feb 2026 (estimated)
- Primary completion
- 12 Feb 2027 (estimated)
- Study completion
- 12 Feb 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor-reactive T cells-GK01 | Experimental | Drug: GK01 InjectionAutologous tumor-reactive T cells injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to understand and sign a written informed consent document.
- At the date of signing ICF, 18 ~75 years old, male or female.
- Advanced lung cancer or esophageal squamous cell carcinoma confirmed by cytology or histopathology, failed or intolerant to standard therapy.
- At least one measurable lesion that has not been irradiated or received other local therapies.
- At least one measurable lesion remains (RECIST 1.1 criteria).
Key exclusion criteria (18 listed)
- History of severe allergy, or hypersensitivity to any component of the drugs used in this study, including but not limited to lymphodepleting chemotherapy drugs, contrast agents for radiological examinations, and excipients of GK01 (such as dimethyl sulfoxide).
- Any investigational drug or systemic anti-tumor therapy within 28 days prior to the start of lymphodepleting chemotherapy preconditioning, or within 5 half-lives of the previous drug.
- Major surgery within 28 days prior to signing the ICF, or planned during the study period.
- Toxicities from previous anti-tumor therapies have not recovered to ≤ Grade 1 or baseline level (according to NCI-CTCAE version 5.0) at the time of signing the ICF, with the exception of alopecia and hyperpigmentation.
- Any uncontrolled active infection requiring parenteral antibiotic, antiviral, or antifungal therapy within 4 weeks prior to signing the ICF or before the first infusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GK01 InjectionAutologous tumor-reactive T cells injection | Drug | Tumor-reactive T cells-GK01 |
Primary outcome
Safety and Tolerability
Time frame: 2 years
The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events)
9 secondary outcomes
Count of TCR copies
Time frame: 2 years
Concentration of Cytokines
Time frame: 2 years
Percentage of Lymphocyte subsets
Time frame: 2 years
Circulating tumor DNA
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Progression-free Survival (PFS)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Duration of Response (DOR)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xu Zhang, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GK01 Injection in people with Advanced Solid Tumors, run by Beijing Geekgene Technology Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BenTong Yu, MD (+86-13870614026, ndyfy02006@ncu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.