Actively Recruiting
Dual-target CLDN18.2/HER2 CAR-NK Cells for Advanced Gastric/GEJ Cancer
Led by Beijing Biotech · Updated on 2026-04-24
36
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This example planning study proposes a phase 1/2 evaluation of an allogeneic, cord-blood-derived dual-target CAR-NK product directed against CLDN18.2 and HER2 (ERBB2) in adults with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma after prior standard systemic therapy. CLDN18.2 is selected as the anchor antigen because it has the more disease-specific gastric/GEJ cell-therapy development footprint, while HER2 is retained as the complementary second antigen to address co-expressing or heterogeneous disease. Phase 1 uses a 3+3 dose-escalation design after fludarabine/cyclophosphamide lymphodepletion followed by three intravenous CAR-NK infusions on Days 0, 3, and 7. Phase 2 expansion evaluates the recommended phase 2 dose and preliminary antitumor activity
CONDITIONS
Official Title
Dual-target CLDN18.2/HER2 CAR-NK Cells for Advanced Gastric/GEJ Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study-specific procedure.
- Age 18 to 75 years.
- Histologically confirmed unresectable locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
- Central confirmation of CLDN18.2-positive disease by immunohistochemistry with membranous CLDN18.2 expression in at least 10% of tumor cells.
- HER2 testing required; HER2-positive defined as IHC 3+ or IHC 2+/ISH+.
- Disease progression after at least 2 prior systemic regimens including fluoropyrimidine and platinum agent unless contraindicated or not tolerated.
- Prior HER2-directed therapy expected if HER2-positive unless unavailable, contraindicated, or not tolerated.
- At least 1 measurable lesion according to RECIST v1.1.
- ECOG performance status 0 or 1.
- Life expectancy of at least 12 weeks.
- Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
- Recovery of prior treatment toxicities to Grade 1 or baseline except alopecia or stable endocrine replacement therapy.
- Willingness to provide archival or fresh tumor tissue for biomarker confirmation.
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during the protocol period.
You will not qualify if you...
- Prior CLDN18.2-targeted or HER2-targeted genetically modified cell therapy (CAR-T, CAR-NK, TCR-T, or similar).
- Active or untreated central nervous system metastases or leptomeningeal disease.
- Active uncontrolled infection including HBV, HCV, or HIV viremia.
- Active autoimmune disease requiring systemic immunosuppression.
- Clinically significant uncontrolled cardiovascular disease including recent myocardial infarction, unstable angina, uncontrolled arrhythmia, or severe heart failure.
- Active gastrointestinal perforation, uncontrolled upper GI bleeding, significant bowel obstruction, or unstable gastric ulcer.
- History of solid-organ transplantation or prior allogeneic hematopoietic stem-cell transplantation with active graft-versus-host disease.
- Requirement for systemic corticosteroids above physiologic replacement within 7 days before lymphodepletion.
- Pregnancy or breastfeeding.
- Another active malignancy requiring systemic therapy except for adequately treated non-melanoma skin cancer, carcinoma in situ, or other allowed low-risk malignancies.
- Any medical, psychiatric, or social condition that would make participation unsafe or interfere with study results.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
shan S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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