A Single-arm, Open-label Study of GK01 in Combination With or Without Chemotherapy for the Adjuvant Treatment of Solid Tumors (GUARDIAN-02)

The Single-arm Open-label Clinical Study Evaluating the Use of GK01 Cell Injection in Combination With or Without Chemotherapy for the Adjuvant Treatment of Solid Tumors

This study is an open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: GK01 Injection

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: JiHui Hao; Phone Number: +86-02223340123; Email: haojihui@tjmuch.com

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Tianjin Cancer hospital Airport hospital
    • Contact: JiHui Hao; Phone Number: +86-02223340123; Email: haojihui@tjmuch.com

Participation Criteria

Eligibility Criteria

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

Description

• Ability to understand and sign a written informed consent document.
• At the date of signing ICF, 18 ~70 years old, male or female.
• Patients with solid tumors confirmed by histopathology (including but not limited to pancreatic cancer, cholangiocarcinoma, gastric cancer, etc.) who are judged by investigator to be capable of undergoing radical total resection of the primary tumor for the purpose of cure.
• No treatment for the primary tumor was received before surgical resection (no induction therapy or recurrent disease).
• The expected survival time is more than 12 weeks;.
• ECOG 0-1 points.

Exclusion Criteria:

• Inoperable or metastatic (Stage IV) solid tumors.
• 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 solid 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.
• Allergy to any components of the drugs planned.
• Previous radiotherapy within 28 days before signing the ICF.
• History of active tuberculosis infection within 1 year before screening.
• 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.
• Investigator-assessed clinically significant thyroid dysfunction.
• Cardiovascular diseases with clinical significance.
• No contraindications to curative resection of the primary tumor.
• Attenuated or inactivated vaccines within 28 days before signing the I form, or planned administration of such vaccines during the screening period.
• Comorbidities or other conditions are likely to affect protocol compliance or suitability for participation in this study.
• 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, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK	Levels of T-cell Receptor copies	2 years
Overall survival (OS )	OS will be assessed from the first GK01 infusion to death from any cause (Assessed based on RECIST criteria)	2 years
Patient Quality of Life	EORTC(European Organisation for Research and Treatment of Cancer) QLG (Quality of Life Group)Core Questionnaire (EORTC QLQ-C30)	2 years
Recurrence free survival(RFS)	RFS will will be assessed from radical surgery to death of any cause (evaluated according to the RECIST criteria).	2 years
PD marker	Concentration levels of serum cytokines, tumor markers and other related markers.	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2025
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): February 14, 2029

Study Registration Dates

• First Submitted: January 11, 2026
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: GUARDIAN-02

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