Actively Recruiting
A Clinical Study of GK02 in Malignant Ascites
Led by Beijing Geekgene Technology Co., LTD · Updated on 2026-01-30
9
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
B
Beijing Geekgene Technology Co., LTD
Lead Sponsor
B
Beijing GoBroad Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of GK02 in Malignant Ascites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Aged 18 to 75 years, male or female
- Have advanced solid tumors confirmed by histology or pathology, with failed at least second-line treatment
- Diagnosed with malignant ascites requiring treatment; ascites volume confirmed above medium level by ultrasound
- ECOG performance status of 0 to 2
- Adequate organ function
- No absolute or relative contraindications for puncture
- No peritoneal treatment for malignant ascites within 14 days before ascites collection
- Female of childbearing age must have a negative urine pregnancy test and agree to effective contraception for 6 months after treatment
- Male participants with fertile partners must agree to use contraception and avoid sperm donation for 6 months after treatment
You will not qualify if you...
- History of severe allergies to study drug components including NMA-LD drugs, contrast agents, DMSO, or antibiotics in cell products
- Presence of central nervous system metastasis
- Toxicity from previous cancer therapy not resolved to grade 1 or baseline
- Current or prior interstitial lung disease or interstitial pneumonia
- Uncontrolled metabolic disorders or secondary reactions increasing medical risk
- Active or history of autoimmune disease likely to recur
- Uncontrolled comorbidities including hypertension or unstable cardiovascular/cerebrovascular disease within 6 months
- Ultrasound showing separation of peritoneal effusion
- Presence of intestinal obstruction
- Use of glucocorticoids or immunosuppressive drugs during trial, except low-dose local transdermal glucocorticoids
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, China
Actively Recruiting
Research Team
C
Changsong Qi, MD, PhD
CONTACT
X
Xu Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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