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

NCT07351903 | Recruiting Phase 1

• 1 other identifier: GUARDIAN-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

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

  2 years

Secondary Outcomes (5)

• PK

  2 years

• Recurrence free survival(RFS)

  2 years

• Overall survival (OS )

  2 years

• Patient Quality of Life

  2 years

• PD marker

  2 years

Study Arms (1)

GK01 injection

EXPERIMENTAL

Autologous tumor-reactive T cells injection

Drug: GK01 Injection

Interventions

GK01 Injection DRUG

Autologous tumor-reactive T cells injection

GK01 injection

Eligibility Criteria

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, China

RECRUITING

Central Study Contacts

Jihui Hao

CONTACT

+86-02223340123; haojihui@tjmuch.com

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: January 20, 2026
• Study Start: October 16, 2025
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): February 14, 2029
• Last Updated: January 20, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)