GK02 for malignant ascites from advanced solid tumors

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

This trial tests whether autologous tumor-reactive T cells (GK02) given into the abdomen can safely reduce malignant ascites in adults with advanced solid tumors.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Geekgene Technology Co., LTD (industry)
• Drugs / interventions: prednisone
• Locations: 1 site (Beijing)
• Trial ID: NCT07378436 on ClinicalTrials.gov

What this trial studies

This single-arm, single-center, open-label early-phase study will enroll up to nine patients in three cohorts to receive autologous tumor-reactive T cells (GK02) derived from their malignant ascites. GK02 will be administered by intraperitoneal infusion and participants will be monitored for safety, tolerability, and preliminary signs of effectiveness in reducing ascites and related symptoms. Exploratory pharmacokinetic and pharmacodynamic analyses will track the behavior and activity of the infused cells after administration. The study targets patients with advanced solid tumors who have failed at least second-line therapy and have clinically significant malignant ascites.

Who should consider this trial

Good fit: Adults aged 18–75 with advanced solid tumors and clinically significant malignant ascites (≥500 mL or ≥3.0 cm depth on ultrasound), ECOG 0–2, adequate organ function, and who have failed at least second-line therapy are ideal candidates.

Not a fit: Patients with poor performance status (ECOG >2), inadequate organ function, small-volume ascites, contraindications to abdominal puncture, or rapidly progressing disease are unlikely to benefit.

Why it matters

Potential benefit: If successful, GK02 could reduce ascites volume, relieve symptoms, and decrease the need for repeated fluid drainage.

How similar studies have performed: Adoptive T-cell therapies have shown major success in blood cancers but remain largely unproven in solid tumors and malignant ascites, so this intraperitoneal autologous T-cell approach is exploratory.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing GoBroad Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Changsong Qi, MD, PhD

Conditions: Malignant Ascites Caused by Advanced Solid Tumors, Advanced solid tumor, Malignant ascites, Gastric cancer