🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07351903
Recruiting Phase 1

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

NCT07351903 · tracked via the Priya Life Science China tracker
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Phase
Phase 1
Started
2025-10-16
Last updated
2026-01-20

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

GK01 Injection →

GK01 Injection: Autologous tumor-reactive T cells injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
* 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Cancer Hospital Airport Hospital Tianjin China Recruiting

More Tianjin Medical University Cancer Institute and Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07351903 on ClinicalTrials.gov ↗ ← All trials in China