LHYY-016 CAR-T cell injection can kill tumor cells by specifically identifying the tumor cell surface antigen Claudin18.2. Research drug: LHYY-016 CAR-T cell injection (Phase Ia) Test type: Single-arm test indication: Claudin 18.

6) serum total bilirubin (TBIL) ≤1.5×ULN (for subjects with Gilbert syndrome, TBIL ≤3×ULN); ALT and AST ≤2.5×ULN (if there is liver metastasis, ALT and AST ≤5×ULN);

7) creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min;

8) Subjects who routinely display urine protein ≥++ should undergo 24-hour quantitative urine protein test, with a test result of 1.0g;

9) Blood oxygen saturation in non-oxygen absorption state ≥95%.

8. Female subjects with fertility: not breastfeeding, the blood pregnancy test during the screening period must be negative, and they agree to take efficient contraception during the treatment period and within 6 months after the last infusion of the study treatment; male subjects with sterilization: they agree to take efficient contraception during the treatment period and within 6 months after the last infusion of the study treatment.

9. The subject voluntarily participated in this study and signed a written informed consent form by himself or his guardian.

exclusion criteria

1, past treatment history that meets any of the following conditions:

1) Subjects who received other chemotherapy (except pretreatment chemotherapy and bridging treatment for the plan stipulated), small molecule targeted therapy, immune and anti-tumor treatment (immune checkpoint inhibitors, etc.), radiotherapy, and major surgery treatment;

2) Within 4 weeks before the first infusion, they received anti-tumor Chinese medicine (with anti-tumor indications approved by NMPA);

3) Those who received live vaccines within 4 weeks before the first infusion (including live attenuated vaccines) and/or were scheduled to receive live vaccines after enrollment;

4) Participated in any interventional clinical trials within 4 weeks before the first infusion (except for overall survival follow-up subjects participating in a study);

5) had received any cellular immunotherapy (including but not limited to CAR-T, CIK, NK cell therapy, etc.);

6) had received targeted Claudin 18.2 Drug or cell therapy (CMG901, CT041, IMAB362);

7) Those with a history of organ transplantation or allogeneic bone marrow transplantation.

2. Those who have not recovered from previous adverse reactions to anti-tumor treatments (i.e., to level 1 or baseline according to CTCAE V5.0); Note: Those with neurotoxicity ≤grade 2, or those with hair loss , or those without infection may be admitted.

3, CNS metastasis or uncontrolled central nervous system metastasis is currently required; or those who are confirmed to have central nervous system metastasis but are not stable through anti-tumor treatment (definition of stable central nervous system metastasis: no new neurological defects caused by central nervous system metastasis, no new lesions were found during central nervous system imaging examination, and no corticosteroid/steroid treatment is required); spinal cord compression , cancer meningitis or leptomy.

4. Other malignant tumors other than gastric/esophageal gastric junction adenocarcinoma or pancreatic cancer within 5 years before the first infusion do not include: negligible risk of metastasis or death (such as 90% expected 5-year OS) and expected to be cured after treatment (such as cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma , localized prostate cancer undergoing radical surgery, ductal carcinoma in situ of breasts treated with radical surgery), or any other tumors that have been cured (without evidence of disease recurrence within 5 years).

5, any of the following cardiovascular risk factors:

1) QTc interval (QTcF) 470 ms corrected by Fridericia method (QTcF is calculated using Fridericia correction formula QTcF = QT/RR 0.33), or a history of congenital long QT interval syndrome;

2) Any history of severe arrhythmia with obvious clinical significance (such as rapid atrial fibrillation, high atrioventricular block, ventricular tachycardia , ventricular fibrillation or torsional ventricular tachycardia);

3) Left ventricular ejaculation fraction (LVEF) 50%;

4) In patients with any of the following diseases within 12 months before the first infusion: myocardial infarction, coronary artery bypass or peripheral artery bypass implantation, heart failure (New York Heart Association Functional Grade III~IV), etc.;

5) Uncontrollable hypertension (although antihypertensive drugs have been treated, systolic blood pressure 150 mmHg, or diastolic blood pressure 100 mmHg), or hypertensive crisis or hypertensive encephalopathy has occurred in the past.

6. Thrombosis or embolization events occurred within 6 months before the first infusion, such as cerebrovascular accident (including transient ischemic attack , except lacunar cerebral infarction), deep venous thrombosis, pulmonary embolism , etc., or subjects who are receiving thrombolytic or anticoagulant treatment such as warfarin, heparin or other similar drugs.