A Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.

Official title

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.

Overview

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.

Interventions

• Drug GK01 injection
  Autologous tumor-reactive T cells injection

Primary outcome measures

• Safety and Tolerability [Time frame: 2 years]

Secondary outcome measures (7)

• Pharmacokinetic [Time frame: 2 years]
• Objective response rate (ORR) [Time frame: 2 years]
• Disease Control Rate (DCR) [Time frame: 2 years]
• Duration of Response (DOR) [Time frame: 2 years]
• Progression-free Survival (PFS) [Time frame: 2 years]
• Overall survival (OS) [Time frame: 2 years]
• Biomarker [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

• Ability to understand and sign a written informed consent document.
• At the date of signing ICF, 18 \~70 years old, male or female.
• Histologically or cytologically confirmed advanced solid tumors, progressed on standard treatment, or intolerant to standard treatment, or without standard treatment; locally recurrent disease must be unsuitable for radical surgical resection or radiotherapy.
• 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.
• Extensive field radiotherapy within 28 days prior to ICF signing, exception of local radiotherapy for symptomatic palliation of non-target lesions.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Peking University Cancer Hospital — Beijing
• Peking University Cancer Hospital — Beijing

Identifiers

NCT: NCT07412665 · GIMINI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗