OncoMatch/Clinical Trials/NCT05472857
Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression
Is NCT05472857 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Claudin 18.2 CAR-T for gastric cancer.
Treatment: Claudin 18.2 CAR-T — This is an open label, multi-center, Phase 1 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in advanced solid tumors with positive CLDN18.2 expression
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Pancreatic Cancer
Ovarian Cancer
Esophageal Carcinoma
Biomarker criteria
Required: CLDN18 positive expression (staining intensity ≥ 1+, positive rate ≥ 10%)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: CAR-T therapy
Received other CAR-T therapy and TCR-T therapy in the past.
Cannot have received: TCR-T therapy
Received other CAR-T therapy and TCR-T therapy in the past.
Cannot have received: gene therapy
Subjects who have received other gene therapy in the past.
Cannot have received: chemotherapy
Exception: bridging therapy allowed if meeting protocol requirements
within 28 days before cell reinfusion, received chemotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments (treatments that met the requirements of the plan before reinfusion, such as bridging therapy except for), or any unmarketed experimental drug treatment
Cannot have received: biological therapy
Exception: bridging therapy allowed if meeting protocol requirements
within 28 days before cell reinfusion, received chemotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments (treatments that met the requirements of the plan before reinfusion, such as bridging therapy except for), or any unmarketed experimental drug treatment
Cannot have received: endocrine therapy
Exception: bridging therapy allowed if meeting protocol requirements
within 28 days before cell reinfusion, received chemotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments (treatments that met the requirements of the plan before reinfusion, such as bridging therapy except for), or any unmarketed experimental drug treatment
Cannot have received: immunotherapy
Exception: bridging therapy allowed if meeting protocol requirements
within 28 days before cell reinfusion, received chemotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments (treatments that met the requirements of the plan before reinfusion, such as bridging therapy except for), or any unmarketed experimental drug treatment
Cannot have received: experimental drug
any unmarketed experimental drug treatment
Cannot have received: traditional Chinese medicine with anti-tumor indications
received traditional Chinese medicine treatment with anti-tumor indications within 2 weeks before cell reinfusion
Lab requirements
Blood counts
adequate organ and bone marrow function
Kidney function
adequate organ and bone marrow function
Liver function
adequate organ and bone marrow function
Cardiac function
no current heart disease requiring treatment or poorly controlled hypertension; LVEF ≥ 50%; no history of coronary heart disease, myocardial infarction, severe heart failure, severe arrhythmia within 6 months before cell reinfusion
The subject has adequate organ and bone marrow function. Within 6 months before cell reinfusion, any of the following cardiac clinical symptoms or diseases: left ventricular ejection fraction (LVEF) < 50%; previous history of coronary heart disease, myocardial infarction, severe heart failure and severe arrhythmia.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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