A Clinical Study GK01 Cell Injection in Subjects With Advanced Lung Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Lung Cancer
• Intervention / Treatment: Drug: GK01 Injection

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Xu Zhang, PhD; Phone Number: +86-13482323610; Email: zhangx@geekgene.cn
• Study Contact Backup: Name: Lin Shen, MD，PhD; Phone Number: +86-010-88196561; Email: doctorshenlin@sina.com

Study Locations

• China
  • Beijing, China
    • Peking University Cancer Hospital
    • Contact: Jun Zhao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Expected survival time more than 3 months.
• Adequate hematologic and organ function.
• No absolute or relative contraindications to surgery, bronchoscopy, or percutaneous procedures.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GK01 injection; Autologous tumor-reactive T cells injection	Drug: GK01 Injection; Autologous tumor-reactive T cells injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	The incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic	Levels of T-cell Receptor copies	2 years
Objective response rate (ORR)	Proportion of subjects achieving complete response (CR) and partial response (PR)	2 years
Progression-free Survival (PFS)	Time from GK01 treatment to disease progression or death	2 years
Disease Control Rate (DCR)	Proportion of subjects achieving best response of CR, PR, or SD treated with GK01	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	2 years
Overall survival (OS)	Time from GK01 treatment to death	2 years
Biomarker	Concentration levels of serum cytokines, tumor markers and other related markers，and ctDNA	2 years

Collaborators and Investigators

• Sponsor: Beijing Geekgene Technology Co., LTD
• Investigators: Principal Investigator: Lin Shen, MD，PhD, Peking University Cancer Hospital & Institute; Principal Investigator: Jun Zhao, MD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Lung Cancer; GK01 Cell Injection
• Other Study ID Numbers: GK01-BZIIT02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No