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Advanced Solid TumorsPhase 1NCT07482319

A Clinical Study GK01 Injection in Subjects With Advanced Malignant Solid Tumors

A Phase 1 study testing GK01 injection in people with Advanced Solid Tumors, run by Beijing Geekgene Technology Co., LTD at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

An Open-label, Single-arm, Phase I Clinical Study of GK01 Cell Injection in the Treatment of Patients with Advanced Malignant Solid Tumors Read more about this study

Who is it for?
Ages 18 to 70 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
15 participants
Where
1 siteChina
Study dates
Apr 2026to Apr 2028
Phase
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understanding and voluntarily signing the Informed Consent Form (ICF) prior to any study-related assessments/procedures;
  • Aged 18 to 70 years old (inclusive) at the time of signing the ICF;
  • Patients with histologically or cytologically confirmed advanced solid tumors (including but not limited to advanced gastric cancer, non-small cell lung cancer, etc.), who have progressed upon the standard of care (SoC), do not tolerate the SoC, or have no SoC;
  • At least one resectable tumor lesion that has not been treated with radiation therapy or other topical therapy, and tissue blocks with the total sum of diameter of resected lesions being 1.5-4 cm or weighing ≥ 1.0 g (sourced from a single lesion or multiple lesions) are available for preparation of autologous tumor-infiltrating lymphocytes;
  • At least 1 measurable lesion (as per RECIST1.1 criteria) even after biopsy for tumor tissue sampling;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at the time of signing the ICF;
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  • Estimated life expectancy> 3 months;
  • Adequate hematological and organ reserve functions;
  • Men of reproductive potential and women of child-bearing potential must agree to use effective contraception from the signing of ICF utill 2 years after the end of study treatment. Women of childbearing potential include pre-menopausal women and those within 2 years after menopause. Women of childbearing potential must have negative serum pregnancy test results at screening.
  • No absolute or relative contraindications to surgery;
  • Any therapy for malignant tumors, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, tumor embolization, or traditional Chinese medicine/herbal therapy with antitumor indications, must be discontinued 14 days prior to tumor tissue sampling;
  • Volunteering to sign the written ICF, having good compliance, and being able to follow the protocol-specified visits or unscheduled visits and other relevant study procedures.

Who cannot join

  • History of serious allergy, or hypersensitivity to any ingredients of the drug to be used in this study, including but not limited to lymphodepleting agents (nab-paclitaxel, cyclophosphamide, fludarabine), contrast agents for imaging examination, contrast media, and GK01 excipients (e.g., dimethyl sulfoxide, etc.);
  • Use of any investigational drug or systemic anti-tumor therapy (except lymphodepleting conditioning regimen) within 28 days (or 5 half-lives of the drug, whichever is more appropriate at the discretion of the investigator) prior to reinfusion;
  • Participation in any clinical trial of biological therapy (except for cell therapy that has been fully metabolized) within 28 days prior to the signing of ICF;
  • Use of extensive radiotherapy within 28 days prior to the signing of ICF, with the exception of topical radiotherapy to non-target lesion(s) that has been administered within 14 days prior to the signing of ICF or is expected to be administered during the study for symptom relief;
  • Major surgery within 28 days prior to the signing of ICF, or planned major surgery during the study period;
  • Toxicities caused by previous anti-tumor therapy, except for alopecia and pigmentation, have not resolved to grade 1 or baseline level (as per NCI-CTCAE Version 6.0) at the time of signing ICF;
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  • Any uncontrolled active infection requiring parenteral antibiotic, antiviral, or antifungal treatment at the time of signing the ICF or within 4 weeks prior to the first reinfusion;
  • Subjects with active autoimmune disorders, or history of autoimmune disorders that may relapse (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or at risk of such diseases;
  • A history of previous bone marrow or organ transplantation;
  • Concomitant or history of interstitial lung disease or interstitial pneumonia;
  • History of active pulmonary tuberculosis within 1 year before screening (excluding subjects with a history of active pulmonary tuberculosis infection more than 1 year ago, who have no evidence of active pulmonary tuberculosis as determined by the investigators at present);
  • History of other primary malignancy within 5 years prior to study treatment
  • Clinically significant cardiovascular diseases; significant, obvious risk or tendency of bleeding (any grade ≥ 3 bleeding or hemorrhage events within 28 days prior to screening, including esophageal variceal bleeding);
  • 15) Metabolic disorders, such as poorly controlled diabetes mellitus (HbA1c ≥ 8.5%) or other non-malignant organ or systemic diseases or secondary reactions to cancer, which may lead to a higher medical risk and/or uncertainty in survival evaluation; 16) Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic CNS compression; or history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, serious brain injury, dementia, Parkinson's disease, etc.; 17) Immunization with attenuated/inactivated vaccine within 28 days prior to the signing of ICF, or planning to receive immunization with attenuated/inactivated vaccine during the screening period; 18) Subjects who need to receive systemic corticosteroids at a dose equivalent to or higher than 10 mg/day of prednisone or other immunosuppressive drugs within 14 days before tumor tissue sampling or during the study period； 19) At screening, subjects who are tested positive for hepatitis B surface antigen (HBsAg) should be excluded; if HBsAg is negative but hepatitis B core antibody (HBcAb) is positive, subjects with hepatitis B virus (HBV) DNA above the lower limit of detection in peripheral blood should be excluded; subjects with positive hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody positive, or both Treponema pallidum-specific and unspecific antibodies positive should also be excluded; 20) Pregnant or lactating women; 21) Presence of complications or other conditions that, in the investigator's opinion, could compromise compliance with the protocol or make the subject otherwise unsuitable for the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ChangSong Qi, MD contact

+86-13811394004

changsongqi@bjmu.edu.cn

Xu Zhang, PhD contact

+86-13482323610

zhangx@geekgene.cn

China1 site

  • Peking University Cancer Hospital

    Beijing

    Lin Shen, MD，PhD, +86-010-88196561, doctorshenlin@sina.com

Other trials in China

About this study

Official title: A Phase I, Open-label, Single-arm Clinical Study of GK01 Cell Injection in Patients With Advanced Malignant Solid Tumors

An Open-label, Single-arm, Phase I Clinical Study of GK01 Cell Injection in the Treatment of Patients with Advanced Malignant Solid Tumors

Being tested
GK01 injection
Keywords
solid tumors, GK01 Cell Injection, dose escalation

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 groups in NCT07482319
Study groupRoleWhat they receive
Tumor-reactive T cells-GK01ExperimentalNot described
Receives: Drug: GK01 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT)

    The highest dose which the patients can tolerate, and the occurence of DLT events.

    Measured: 28 days

  2. Safety and Tolerability

    Incidence, severity, and causality of adverse events (AEs) and serious adverse events (SAEs).

    Measured: 2 year

Secondary outcomes (5)

  1. Pharmacokinetic

    Levels of T-cell Receptor copies

    Measured: 2 years

  2. Objective response rate (ORR)

    Proportion of subjects achieving complete response (CR) and partial response (PR)

    Measured: 2 years

  3. Disease Control Rate (DCR)

    Proportion of subjects achieving best response of CR, PR, or SD treated with GK01

    Measured: 2 years

  4. Progression-free Survival (PFS)

    Time from GK01 treatment to disease progression or death

    Measured: 2 years

  5. 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.

  1. First posted19 Mar 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07482319
Sponsor's protocol ID
GK01P1-01
Status last verified
Mar 2026
First submitted
16 Mar 2026
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A 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 12 inclusion and 14 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 23 Mar 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 ChangSong Qi, MD (+86-13811394004, changsongqi@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07482319.

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 23 Mar 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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