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

NCT07407985 | Active Not Recruiting Phase 1

• 1 other identifier: GUARDIAN-03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

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

  2 years

Secondary Outcomes (6)

• Pharmacokinetic

  2 years

• Objective response rate (ORR)

  2 years

• Progression-free Survival（PFS）

  2 years

• Duration of Response（DOR）

  2 years

• Overall survival（OS）

  2 years

Other Outcomes (1)

• Biomarker

  2 years

Study Arms (1)

GK01 PD-1 monoclonal

EXPERIMENTAL

GK01 combination with PD-1 monoclonal antibody

Drug: GK01 combination with PD-1 monoclonal antibody

Interventions

GK01 combination with PD-1 monoclonal antibody DRUG

GK01 combination with PD-1 monoclonal antibody

GK01 PD-1 monoclonal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Geekgene Technology Co., LTD: collaborator
• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: February 12, 2026
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 3, 2027
• Study Completion (Estimated): December 2, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)