Actively Recruiting
To Evaluate the Efficacy of CT041 in Sequential Treatment After First-line Treatment of Advanced Gastric/Esophagogastric Junction Adenocarcinoma
Led by Beijing GoBroad Hospital · Updated on 2025-10-01
20
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma
CONDITIONS
Official Title
To Evaluate the Efficacy of CT041 in Sequential Treatment After First-line Treatment of Advanced Gastric/Esophagogastric Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to voluntarily participate and complete all trial procedures
- Age between 18 and 75 years, any gender
- Pathologically confirmed unresectable locally advanced or metastatic gastric/esophagogastric junction adenocarcinoma
- Tumor tissue positive for CLDN18.2 with staining intensity 2+ in at least 40% of tumor cells
- Completed 12 weeks of first-line treatment without disease progression
- First-line treatment includes fluoropyrimidine + platinum (with or without taxane), with or without immunotherapy or zolbetuximab
- ECOG performance status of 0 or 1 within 7 days before apheresis
- Adequate venous access for apheresis without contraindications
- Laboratory tests within 7 days before apheresis meet specified blood counts, liver and kidney function, and coagulation criteria
- Female participants of childbearing potential have a negative pregnancy test and agree to use effective contraception for 12 months after treatment
- Male participants sexually active with females of childbearing potential agree to use effective contraception or abstain for 12 months after treatment
You will not qualify if you...
- Tumor tissue with high HER2 expression
- Presence or high risk of gastrointestinal bleeding, perforation, or obstruction within 3 months
- Prior anti-tumor therapy other than allowed first-line treatment
- Systemic anti-tumor treatment within 21 days prior to apheresis
- Major surgery or significant trauma within 4 weeks prior to apheresis without recovery
- Previous genetic engineering cell therapy such as CAR-T or TCR-T
- Unresolved toxicities from prior treatments above Grade 1 (except certain exceptions)
- Positive for HIV, Treponema pallidum, or active hepatitis C infection
- Active infections requiring systemic treatment
- Clinically significant thyroid dysfunction or severe complications
- Systemic corticosteroid use within 14 days prior to apheresis
- Need for long-term anticoagulation or antiplatelet therapy (except prophylactic use for venous access)
- Allergies to study drugs or components
- Known or suspected central nervous system metastases
- Extensive metastases in lung, liver, or bone
- Clinical symptoms requiring treatment for abdominal or pleural effusion
- Previous organ transplantation or awaiting transplantation
- Recent live vaccine use
- Active autoimmune diseases requiring immunosuppressants
- Certain cardiovascular or pulmonary diseases unsuitable for trial
- Oxygen saturation 95% without oxygen
- Significant neurological or psychiatric disorders
- Poor glycemic control or complications
- Other conditions judged unsuitable by investigator
- Other malignancies within past 5 years except certain low-risk types
- Pregnancy or lactation
- Unable or unwilling to comply with trial requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
BeijingGoBroadH
Beijing, China, 100142
Actively Recruiting
Research Team
L
Lifeng Zhang Lifeng Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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