Advanced Lung CancerEarly Phase 1NCT07673419
A Clinical Study GK01 Cell Injection in Subjects With Advanced Lung Cancer
A Early Phase 1 study testing GK01 Injection in people with Advanced Lung Cancer, run by Beijing Geekgene Technology Co., LTD at 2 sites in China.
Trial summary
A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Participants with Advanced Lung Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Lung Cancer
- 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
- 2 sitesChina
- Study dates
- Jul 2026to Jul 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.
- Histologically or cytologically confirmed recurrent, or metastatic advanced lung cancer, progressed on standard treatment, or intolerant to standard treatment.
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Peking University Cancer Hospital
Beijing
Lin Shen, MD，PhD, +86-010-88196561, doctorshenlin@sina.com
Peking University Cancer Hospital
Beijing
Jun Zhao, MD
About this study
Official title: A Single-Arm Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Participants With Advanced Lung Cancer
A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Participants with Advanced Lung Cancer
- Conditions
- Advanced Lung Cancer
- Being tested
- GK01 Injection
- Keywords
- GK01 Cell Injection, Advanced Lung Cancer
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 |
|---|---|---|
| GK01 injection | 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 of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Measured: 2 years
Secondary outcomes (7)
Biomarker
Concentration levels of serum cytokines, tumor markers and other related markers，and ctDNA
Measured: 2 years
Pharmacokinetic
Levels of T-cell Receptor copies
Measured: 2 years
Objective response rate (ORR)
Proportion of subjects achieving complete response (CR) and partial response (PR)
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
Progression-free Survival (PFS)
Time from GK01 treatment to disease progression or death
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 posted29 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CancerStudies 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)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, MD，PhD, Principal investigator, Peking University Cancer Hospital & InstituteJun Zhao, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673419
- Sponsor's protocol ID
- GK01-BZIIT02
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Participants With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT07673419
- Acronym / sponsor ID
- GK01-BZIIT02
- Conditions
- Advanced Lung Cancer
- Keywords
- GK01 Cell Injection, Advanced Lung Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Geekgene Technology Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Jun 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-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Participants with Advanced Lung Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GK01 injection | 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.
- Histologically or cytologically confirmed recurrent, or metastatic advanced lung cancer, progressed on standard treatment, or intolerant to standard treatment.
- 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 | GK01 injection |
Primary outcome
Safety and Tolerability
Time frame: 2 years
The incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)
7 secondary outcomes
Biomarker
Time frame: 2 years
Pharmacokinetic
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Duration of Response (DOR)
Time frame: 2 years
Progression-free Survival (PFS)
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 29 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Lin Shen, MD，PhD principal investigator
Peking University Cancer Hospital & Institute
Jun Zhao, MD principal investigator
Peking University Cancer Hospital & Institute
2 sites 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 Lung Cancer, run by Beijing Geekgene Technology Co., LTD at 2 sites 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: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Lin Shen, MD，PhD (+86-010-88196561, doctorshenlin@sina.com), 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 29 Jun 2026.