A Clinical Study of GK02 in Malignant Ascites

A Single-Arm, Single-Center, Open-Label Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Autologous Tumor-Reactive T Cells(GK02) Derived From Malignant Ascites Caused by Advanced Solid Tumors

A single-arm, single-center, open-label clinical study comprising three cohorts, evaluating the safety, preliminary efficacy, and pharmacokinetic/ pharmacodynamic (PK/PD) characteristics of autologous tumor-reactive T cells (GK02) derived from malignant ascites caused by advanced solid tumors.

The trial initially plans to enroll 9 subjects with malignant ascites caused by advanced solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Malignant Ascites Caused by Advanced Solid Tumors
• Intervention / Treatment: Drug: GK02

Detailed Description

To evaluate the safety and preliminary efficacy of an investigational cell therapy, Autologous Tumor-reactive T Cells (GK02) derived from malignant ascites caused by advanced solid tumors.

Following intraperitoneal infusion of GK02, the safety and tolerability of the subjects will be observed, the preliminary effectiveness of the investigational product GK02 in treating malignant ascites will be evaluated, and the pharmacokinetic/pharmacodynamic (PK/PD) characteristics post-administration will be exploratively assessed.

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Changsong Qi, MD, PhD; Phone Number: +86-13811394004; Email: changsongqi@bjmu.edu.cn
• Study Contact Backup: Name: Xu Zhang, PhD; Phone Number: +86-13482323610; Email: zhangx@geekgene.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing GoBroad Hospital
    • Contact: Changsong Qi, MD, PhD; Phone Number: +86-13811394004; Email: changsongqi@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ability to understand and sign a written informed consent document；
2. At the date of signing ICF, 18 ~75 years old, male or female；
3. Patients with advanced solid tumors confirmed by histology or pathology to have failed at least second-line treatment (treatment failure is defined as progression after treatment or intolerance after treatment), including but not limited to gastric cancer, colorectal cancer, pancreatic cancer, ovarian cancer, etc.；
4. Pathological diagnosis or clinical diagnosis of malignant ascites, and the researcher determines that treatment for malignant ascites is necessary; During screening, the ascites volume was confirmed to be above the medium level by ultrasound (the maximum depth of ascites in the supine position was ≥3.0cm, and the total volume was ≥500ml);
5. ECOG 0-2 points;
6. Adequate organ functions;
7. There are no absolute or relative contraindications for puncture；
8. No peritoneal treatment for malignant ascites has been carried out within 14 days prior to the collection of malignant ascites;
9. Female of childbearing age who have a negative urine pregnancy test during the screening period and agree to take effective contraceptive measures for at least 6 months after perfusion; Male subjects whose partners are fertile must agree to use effective contraceptive methods and avoid sperm donation for at least six months after perfusion.

Exclusion Criteria:

1. Those with a history of severe allergies or allergic reactions to any components of the drugs to be used in this study, including but not limited to NMA-LD drugs, contrast agents and contrast agents used in imaging examinations, excipients such as dimethyl sulfoxide (DMSO) and antibiotics in cell products;
2. Central nervous system (CNS) metastasis is present;
3. Toxicity from previous antitumor therapy did not return to grade 1 or baseline levels (CTCAE version 5.0);
4. Accompanied or prior to interstitial lung disease or interstitial pneumonia;
5. Uncontrolled metabolic disorders, such as those in patients with diabetes (glycated hemoglobin ≥8.5%), or secondary reactions to other non-malignant organ or systemic diseases or cancer, which can lead to higher medical risks and/or uncertainties in survival assessment;
6. An autoimmune disease that is active or has previously suffered from and is likely to recur;
7. Uncontrolled comorbidities include but are not limited to uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) or any unstable cardiovascular and cerebrovascular diseases that occurred within 6 months prior to treatment enrollment;
8. Ultrasound indicates the separation of peritoneal effusion;
9. Patients with intestinal obstruction;
10. Patients with comorbidities or active autoimmune diseases that require the use of glucocorticoids or other immunosuppressive drugs during the trial period, excluding local transdermal absorption of glucocorticoids (i.e., no more than 5mg/ day of prednisone or equivalent doses of other glucocorticoids);
11. Women who are pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tumor-reactive T cells-GK02; Treatment with autologous tumor-reactive T cells (GK02) derived from malignant ascites caused by advanced solid tumors.	Drug: GK02; Autologous tumor-reactive T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AEs	Incidence and severity of AEs, including but not limited to vital signs, physical examination, laboratory tests. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.	12 months
Incidence of DLTs	Number of DLTs (dose limiting toxicities) during the first 28 days after the administrations of GK02 in each cohort.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the volume of malignant ascites	Change in malignant ascites volume at 28D（day）、2、3、4、5、6、9、12M（month） after GK02 treatment compared to baseline (prior to GK02 infusion).	12 months
PuFS	From the first infusion of GK02 to the first paracentesis for ascites drainage or death from any cause.	12 months
OS	OS will be assessed from the first GK02 infusion to death from any cause.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of TCR copies	T-cell receptor sequencing (TCR-seq) by obtaining the copy number of the target GK02 T-cell receptors (TCRs) in peripheral blood and malignant ascites： Cmax、Tmax、AUC0-t、AUC0-inf、λz、T1/2.	12 months
Concentration of Cytokines	IL-1β、IL-2、IL-4、IL-6、IL-8、IL-10、 IL-12、TGF-b1、IFN-γ and TNF-α	12 months
Percentage of Lymphocyte subsets	Total T cells、Th/Ti cells、Ts/Tc cells、NK cells	12 months
Proportion of EpCAM + cells	Proportion of EpCAM+ cells among cells	12 months

Collaborators and Investigators

• Sponsor: Beijing Geekgene Technology Co., LTD
• Collaborators: Beijing GoBroad Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2025
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): December 17, 2027

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Gastric cancer; Advanced solid tumor; Malignant ascites
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: GK02-GBIIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No