Advanced Claudin18.2+ Solid Tumors
Conditions
Interventions
Experimental group:PM3023 injection
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research; fully understand this research and sign informed consent voluntarily; be willing to follow and have the ability to complete all research procedures; 2. Male or female, aged 18 to 70 years (rounded down, including boundary values); 3. Histologically or cytologically confirmed CLDN18.2 positive, patients with advanced malignant solid tumors (such as gastric/gastroesophageal junction cancer) who have failed standard therapy, or who have no standard therapy or who cannot tolerate standard therapy. , pancreatic cancer, etc.); 4. According to RECIST 1.1 criteria, there is at least one measurable lesion, such as a lesion that has received local radiotherapy in the past, only if there is clear disease progression after radiotherapy, and the previously irradiated lesion is not the only measurable lesion, it can be considered. The lesions are measurable lesions; 5. All subjects are required to provide tumor tissue specimens, which must be qualified archived specimens within 12 months before signing the informed consent, or fresh biopsy specimens collected within 6-8 weeks before cell reinfusion (bone biopsy is not accepted. If the subject cannot provide specimens that meet the above time limit due to special reasons, with the consent of the medical supervisor of the partner, the subject will be subject to can also participate in the screening; 6. Having adequate organ function, defined as follows: (1) Blood system (without receiving medical support such as blood transfusion and granulocyte colony-stimulating factor within 14 days before cell reinfusion): 1) Neutrophil count (ANC) >= 1.5 x 10^9/L; 2) White blood cells (WBC) >=3.0 x 10^9/L; 3) Platelet count (PLT) >= 90 x 10^9/L; 4) Hemoglobin (Hb) >= 90g/L; (2) Liver function: 1) Total bilirubin (TBIL) = 50 ml/min (Cockcroft-Gault formula: ([140-age] x weight [kg] x [0.85, for women only])/(72 x creatinine (mg) /dl)))); 2) Urine protein qualitative = 2+, a 24-hour urine protein quantitative examination is required, and if 24-hour urine protein quantitative = 12 weeks; 9. After assessment, enough PBMC cells can be collected in the subject to prepare the infusion cells; 10. After evaluation, the number of prepared reinfusion cells is sufficient and of qualified quality, which can be used for clinical reinfusion; 11. Female subjects with fertile potential have a negative blood pregnancy result within 3 days before the cell reinfusion, and are willing to abstain from sex or take medically approved high-efficiency drugs from the time of signing th
Exclusion criteria
Exclusion criteria: 1. History of severe allergic disease, severe drug allergy (including unmarketed experimental drugs) or known allergy to any component of the recommended drugs (including pretreatment drugs) in this program; 2. Those who have received gene therapy or cell therapy or tumor vaccine in the past; 3. Previously received drugs or cell therapy targeting CLDN18.2; 4. The subject suffers from gastric outlet obstruction or persistent and repeated vomiting; 5. Unstable/active ulcers or investigator-determined uncontrolled or severe gastrointestinal bleeding within 6 weeks; 6. Adverse reactions of previous anti-tumor therapy have not recovered to grade 1 or below according to CTCAE 5.0 (except for toxicities judged by the investigator to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, and stable hypothyroidism after hormone replacement therapy) Wait); 7. Evidence of major bleeding disorders or other significant bleeding risk: (1) History of intracranial hemorrhage or intraspinal hemorrhage; (2) The tumor lesions invade the large blood vessels and have obvious bleeding risk; (3) Thrombosis or embolic events occurred within 6 months before cell reinfusion (except for asymptomatic and non-treatment-free intermuscular venous thrombosis); (4) Clinically significant hemoptysis or tumor hemorrhage occurred within 1 month before cell reinfusion; (5) Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) has been used within 2 weeks before cell reinfusion; (6) Antiplatelet drug therapy, such as aspirin (>325 mg/day), clopidogrel (>75 mg/day), dipyridamole, ticlopidine, or cilox, within 10 days before cell reinfusion tazol, etc., or those who require long-term antiplatelet therapy. 8. Received the following treatments or drugs before cell reinfusion: (1) Inoculated with live attenuated vaccine within 28 days before cell reinfusion; (2) Received chemotherapy, biological therapy, endocrine therapy and other anti-tumor treatments within 28 days before the cell reinfusion (except for the treatment that meets the requirements of the protocol before the reinfusion), or any treatment with unmarketed experimental drugs; the following conditions also need to be excluded : Received nitrosourea or mitomycin C treatment within 6 weeks before cell reinfusion; received oral fluorouracil and small doses 2 weeks before cell reinfusion or within 5 half-lives of the drug (whichever is longer) Molecular targeted drug therapy; received traditional Chinese medicine treatment with anti-tumor indications within 2 weeks before cell reinfusion; (3) Received systemic immunostimulant or immunosuppressive therapy (such as IFN-a, IL-2, Tripterygium wilfordii) within 4 weeks before the start of study treatment, or is still within the 5 half-life of the therapeutic drug (whichever is shorter). Senior citizens); (4) Received corticosteroids within 2 weeks before cell reinfusion, or it is expected that corticosteroid treatment may be required during blood collection, cell collection or cell reinfusion; except for the following cases: short time (<=7 days), low dose Corticosteroids at 10 mg/d prednisone or equivalent for the prevention or treatment of non-autoimmune conditions; topical, intranasal, intraocular, intraarticular or inhaled corticosteroids; 9. Known leptomeningeal metastases, or uncontrolled or symptomatic central nervous system metastases manifested by clinical symptoms, cerebral edema, spinal cord compres
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities;objective response rate;disease control rate; | — |
Countries
China
Contacts
Public ContactZhang Yi
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed