GK01 cell injections for advanced lung and esophageal squamous cell cancers

A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Subjects With Advanced Solid Tumors.

This study tests whether injections of GK01 cells are safe and can shrink tumors or slow growth in people with advanced lung cancer or esophageal squamous cell carcinoma who no longer respond to standard treatments.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Geekgene Technology Co., LTD (Industry-sponsored)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Nanchang)
• Trial ID: NCT07414316 on ClinicalTrials.gov

What this trial studies

This is a single-center, single-arm, open-label early-phase 1 study enrolling adults with advanced lung cancer or esophageal squamous cell carcinoma refractory or intolerant to standard therapy. Participants with at least one measurable lesion and ECOG 0-1 will receive GK01 cell injections and be followed for safety and preliminary signs of tumor response. Tumor response will be monitored by radiologic assessments using RECIST 1.1 and by clinical and laboratory safety testing. The main focus is on safety and tolerability, with secondary observations of any anti-tumor activity.

Who should consider this trial

Good fit: Adults aged 18–75 with advanced lung cancer or esophageal squamous cell carcinoma who are refractory or intolerant to standard treatments, have at least one measurable lesion, ECOG 0–1, and adequate organ function are the intended candidates.

Not a fit: Patients with poor performance status (ECOG >1), very limited life expectancy, no measurable lesions, or contraindications to the required procedures are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, GK01 injections could offer a new cell-based option to control tumor growth in patients who have exhausted standard therapies.

How similar studies have performed: Cell therapies have produced clear successes in some blood cancers but have shown limited and inconsistent benefits in solid tumors, so this approach remains largely experimental for solid cancers.

Eligibility criteria

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.
* 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.

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.

Where this trial is running

Nanchang

• The First Affiliated Hospital of Nanchang University — Nanchang, China (Recruiting)

Study contacts

• Study coordinator: BenTong Yu, MD

Conditions Advanced Solid Tumors