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Solid TumorsPhase 1GK01IIT-TZ03NCT07407985

A Clinical Study to Evaluate GK01 Cell Injection in Combination With PD-1 Monoclonal Antibody for Advanced Solid Tumors

A Phase 1 study testing GK01 combination with PD-1 monoclonal antibody in people with Solid Tumors, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a open-label, single-arm clinical trial designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of the GK01 cell injection in combination with a PD-1 monoclonal antibody for the treatment of advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Solid Tumors
What is being tested?
GK01 combination with PD-1 monoclonal antibody
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
4 Dec 2025to 2 Dec 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

  • Informed Consent Form (ICF) .
  • Aged 18 to 70 years (inclusive) at the time of signing the ICF.
  • Histologically or cytologically confirmed advanced solid tumors that are metastatic or locally recurrent (including but not limited to small cell lung cancer, non-small cell lung cancer, gastric cancer, colorectal cancer, etc.);
  • ECOG score of 0 ~1 .
  • Expected survival time is more than 12 weeks.
  • Negative blood pregnancy test for females of childbearing potential is required.

Who cannot join

  • Patients with central nervous system (CNS) metastasis, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc.
  • History of bone marrow or organ transplantation;
  • History of other primary malignancies within 5 years prior to study treatment
  • Hepatitis B surface antigen (HBsAg) positivity; With negative HBsAg but 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.
  • Patients with a known allergy to any component of the study drugs.
  • Received treatment with anti-PD-1, anti-PD-L1 therapeutic antibodies, or drugs targeting this pathway.
Show all 23Show fewer
  • Received any investigational drug or systemic anticancer therapy within 28 days before infusion (or 5 half-lives of the drug, whichever is considered more appropriate by the investigator).
  • Received wide-field radiotherapy within 28 days prior to signing the ICF, with the exception of palliative radiotherapy to non-target lesions for symptom relief, administered at least 14 days before signing the ICF or planned during the study period.
  • Undergone major surgery within 28 days prior to signing the ICF, or are scheduled to undergo major surgery during the study period.
  • At the time of signing the ICF, any toxicity from prior anti-cancer therapy (except alopecia and pigmentation) that has not recovered to Grade 1 (excluding lymphocytopenia) or to baseline level (according to NCI CTCAE version 5.0).
  • Any uncontrolled active infection requiring parenteral (IV) antibiotic, antiviral, or antifungal treatment at the time of signing the ICF or within 4 weeks before the first infusion.
  • History of active tuberculosis infection within 1 year prior to screening (subjects with a history of active tuberculosis infection more than 1 year ago are eligible if, in the investigator's judgment, there is no current evidence of active tuberculosis).
  • Concurrent or previous history of interstitial lung disease or interstitial pneumonia; presence of chronic lung disease or other respiratory conditions that significantly impair lung function.
  • Diagnosis of active autoimmune disease or a history of autoimmune disease that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or at risk of such conditions.
  • Required treatment with systemic corticosteroids (at a dose equivalent to or higher than 10 mg/day of prednisone) or other immunosuppressive medications within 2 weeks before signing the ICF or during the study period.
  • Clinically significant thyroid dysfunction as assessed by the investigator.
  • Clinically significant cardiovascular diseases.
  • Insufficient bone marrow reserve or insufficient organ function.
  • Bleeding within 6 months before signing the ICF; clinically significant bleeding requiring medical intervention within 28 days before screening, including esophageal variceal bleeding.
  • Poorly controlled pleural, peritoneal, or pericardial effusion during the screening period (e.g., presence of clinical symptoms, fluctuating volume, requiring repeated drainage, or the use of oral diuretics). Presence of ascites detectable on physical examination, clinical symptoms caused by ascites, or the need for special management such as repeated drainage or intraperitoneal drug infusion (subjects with only a small amount of ascites detectable solely via imaging may be considered for enrollment).
  • Administration of attenuated or inactivated vaccines within 28 days before signing the ICF, or planned administration of such vaccines during the screening period.
  • The investigator considers that the subject's complications or other conditions may affect compliance with the protocol or that the subject is unsuitable for participation in this study.
  • Female subjects who are pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin

Other trials in China

About this study

Official title: A Open-label, Single-arm Clinical Trial Designed to Evaluate the Safety, Pharmacokinetic , and Efficacy of the GK01 Cell Injection in Combination With a PD-1 Monoclonal Antibody for the Treatment of Advanced Solid Tumors.

This study is a open-label, single-arm clinical trial designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of the GK01 cell injection in combination with a PD-1 monoclonal antibody for the treatment of advanced solid tumors.

Conditions
Solid Tumors
Being tested
GK01 combination with PD-1 monoclonal antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GK01 combination with PD-1 monoclonal antibodyDrug

    GK01 combination with PD-1 monoclonal antibody

Study groups in NCT07407985
Study groupRoleWhat they receive
GK01 PD-1 monoclonalExperimentalGK01 combination with PD-1 monoclonal antibody
Receives: Drug: GK01 combination with PD-1 monoclonal antibody

What is being measured

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

  1. Safety and Tolerability

    The incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events).

    Measured: 2 years

Secondary outcomes (6)

  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. Progression-free Survival（PFS）

    Time from GK01 treatment to disease progression or death

    Measured: 2 years

  4. 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

  5. Overall survival（OS）

    Time from GK01 treatment to death

    Measured: 2 years

  6. Disease Control Rate（DCR）

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

    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 posted12 Feb 2026
  2. Study start4 Dec 2025
  3. Primary completion3 Dec 2027 (estimated)
  4. Study completion2 Dec 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07407985
Sponsor's protocol ID
GUARDIAN-03
Acronym
GK01IIT-TZ03
Status last verified
Jan 2026
First submitted
11 Jan 2026
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
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 combination with PD-1 monoclonal antibody in people with Solid Tumors, run by Tianjin Medical University Cancer Institute and Hospital 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 6 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 12 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?

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT07407985.

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 12 Feb 2026.

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