A Clinical Study of GK02 in Malignant Ascites (NCT07378436) | Clinical Trial Compass
RecruitingEarly Phase 1
A Clinical Study of GK02 in Malignant Ascites
China9 participantsStarted 2025-09-16
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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；
✓. 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.；
✓. 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);
✓. ECOG 0-2 points;
✓. Adequate organ functions;
✓. There are no absolute or relative contraindications for puncture；
✓. No peritoneal treatment for malignant ascites has been carried out within 14 days prior to the collection of malignant ascites;
Exclusion criteria
✕. 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;
. Central nervous system (CNS) metastasis is present;
✕. Toxicity from previous antitumor therapy did not return to grade 1 or baseline levels (CTCAE version 5.0);
✕. Accompanied or prior to interstitial lung disease or interstitial pneumonia;
✕. 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;
✕. An autoimmune disease that is active or has previously suffered from and is likely to recur;
✕. 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;
✕. Ultrasound indicates the separation of peritoneal effusion;