Malignant Ascites Caused by Advanced Solid TumorsEarly Phase 1NCT07378436
A Clinical Study of GK02 in Malignant Ascites
A Early Phase 1 study testing GK02 in people with Malignant Ascites Caused by Advanced Solid Tumors, run by Beijing Geekgene Technology Co., LTD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Ascites Caused by Advanced Solid Tumors
- What is being tested?
- GK02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2025to 17 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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 subjects whose partners are fertile must agree to use effective contraceptive methods and avoid sperm donation for at least six months after perfusion.
Who cannot join
- 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;
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- 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;
- 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 (i.e., no more than 5mg/ day of prednisone or equivalent doses of other glucocorticoids);
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing
Changsong Qi, MD, PhD, +86-13811394004, changsongqi@bjmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Being tested
- GK02
- Keywords
- Advanced solid tumor, Malignant ascites, Gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GK02Drug
Autologous tumor-reactive T cells
| Study group | Role | What they receive |
|---|---|---|
| Tumor-reactive T cells-GK02 | Experimental | Treatment with autologous tumor-reactive T cells (GK02) derived from malignant ascites caused by advanced solid tumors. Receives: Drug: GK02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Incidence of DLTs
Number of DLTs (dose limiting toxicities) during the first 28 days after the administrations of GK02 in each cohort.
Measured: 28 days
Secondary outcomes (3)
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).
Measured: 12 months
PuFS
From the first infusion of GK02 to the first paracentesis for ascites drainage or death from any cause.
Measured: 12 months
OS
OS will be assessed from the first GK02 infusion to death from any cause.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start16 Sep 2025
- Primary completion17 Dec 2026 (estimated)
- Study completion17 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Ascites Caused by Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Geekgene Technology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing GoBroad Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378436
- Sponsor's protocol ID
- GK02-GBIIT
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07378436
- Acronym / sponsor ID
- GK02-GBIIT
- Keywords
- Advanced solid tumor, Malignant ascites, Gastric cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Beijing Geekgene Technology Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Beijing GoBroad Hospital
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 17 Dec 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor-reactive T cells-GK02 | Experimental | Drug: GK02Treatment with autologous tumor-reactive T cells (GK02) derived from malignant ascites caused by advanced solid tumors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GK02Autologous tumor-reactive T cells | Drug | Tumor-reactive T cells-GK02 |
Primary outcome
Incidence of AEs
Time frame: 12 months
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.
Incidence of DLTs
Time frame: 28 days
Number of DLTs (dose limiting toxicities) during the first 28 days after the administrations of GK02 in each cohort.
3 secondary outcomes
Changes in the volume of malignant ascites
Time frame: 12 months
PuFS
Time frame: 12 months
OS
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GK02 in people with Malignant Ascites Caused by Advanced Solid Tumors, run by Beijing Geekgene Technology Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changsong Qi, MD, PhD (+86-13811394004, changsongqi@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.