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New treatment option for Malignant Ascites Caused by Advanced Solid Tumors
Official title A Clinical Study of GK02 in Malignant Ascites
ClinicalTrials.gov ID: NCT07378436
What this study is testing
What is GK02?
GK02 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant ascites caused by advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Pathological diagnosis or clinical diagnosis of malignant ascites, and the researcher determines that treatment for malignant ascites is necessary...
- ECOG 0-2 points;
You likely can't join if
- 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...
- 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...
- An autoimmune disease that is active or has previously suffered from and is likely to recur;
See the full eligibility 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)...
- 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...
- 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;
- 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 people whose partners are...
- 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...
- 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...
- 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...
- Ultrasound indicates the separation of peritoneal effusion;
- Patients with intestinal obstruction;
- 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...
- Women who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.