A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.

NCT07414316 | Recruiting Early Phase 1

• 1 other identifier: GK01-NCDXIIT01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A Single-Center, Open-Label Clinical Study to Evaluate the Safety, Preliminary Efficacy of GK01 Cell Injection in Subjects with Advanced Solid Tumors Refractory or Intolerant to Standard Therapy

Conditions

Advanced 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 (9)

• Count of TCR copies

  2 years

• Concentration of Cytokines

  2 years

• Percentage of Lymphocyte subsets

  2 years

• Circulating tumor DNA

  2 years

• Objective response rate (ORR)

  2 years

Study Arms (1)

Tumor-reactive T cells-GK01

EXPERIMENTAL

Autologous tumor-reactive T cells injection

Drug: GK01 Injection

Interventions

GK01 Injection DRUG

Autologous tumor-reactive T cells injection

Tumor-reactive T cells-GK01

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and sign a written informed consent document.
• At the date of signing ICF, 18 \~75 years old, male or female.
• Advanced lung cancer or esophageal squamous cell carcinoma confirmed by cytology or histopathology, failed or intolerant to standard therapy.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: collaborator
• Beijing Geekgene Technology Co., LTD: lead

Study Sites (1)

The First Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

Central Study Contacts

BenTong Yu, MD

CONTACT

+86-13870614026; ndyfy02006@ncu.edu.cn

Xu Zhang, PhD

CONTACT

Study Design

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

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 17, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): February 12, 2027
• Study Completion (Estimated): February 12, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)