Overview

A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection.

To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others.

Eligibility

Before conducting tumor-associated lymph node sampling, it is necessary to verify that

subjects meet the inclusion criteria marked with an asterisk (*). These criteria include:

1. * being between the ages of 18 and 75;
2. having metastatic or locally advanced refractory/recurrent malignant solid tumors that have failed standard therapy or have failed to tolerate standard treatment;
3. having at least one measurable target lesion;
4. * voluntarily participating and signing an informed consent form;
5. * having at least one resectable tumor-associated lymph node from which T cells can be successfully isolated;
6. * having an ECOG score of 0-1;
7. * having an expected survival of more than 6 months;
8. * female subjects with fertility potential must have a negative pregnancy test, and all men and women with fertility potential must consent to using medically effective contraception during the study period and for 12 months after the last dose of the study medication;
9. * being willing to regularly come to the hospital for treatment, testing, evaluation, and management as required during the entire study period.

        Before sampling tumor-associated lymph nodes, it is important to confirm that the subject
        does not meet any of the exclusion criteria marked with an asterisk (*). These criteria
        include：
          1. * Experiencing moderate to severe infection or at risk of opportunistic infection;
          2. * Present with active autoimmune disease (other than vitiligo or childhood
             asthma/allergies that have healed);
          3. * Uncontrolled concomitant disease, including but not limited to symptomatic
             congestive heart failure, unstable angina pectoris, arrhythmias (excluding stable
             atrial fibrillation), and significant carotid stenosis.
          4. * Acute systemic infections, coagulation disorders or other serious cardiopulmonary
             diseases;
          5. Patients who have used large amounts of glucocorticoids or other immunosuppressants
             within 4 weeks;
          6. * A history of severe hypersensitivity to any of the drugs used in this study;
          7. Known uncontrolled central nervous system (CNS) metastases and/or cancerous
             meningitis;
          8. * Pregnant and lactating women, as well as women and men who were unable to cooperate
             with contraception during the study period;
          9. Previous anti-tumor therapy: within four weeks of radiotherapy, chemotherapy, one week
             after TKI inhibitor treatment, four weeks of investigational therapy or four
             half-lives, whichever is shorter;
         10. * Enroll in another clinical study at the same time, unless it is an observational,
             non-interventional clinical study or the follow-up period of an interventional study;
         11. * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem
             cell transplantation;
         12. * Known history of interstitial lung disease. Exclude subjects with high suspicion of
             interstitial pneumonia; Or may interfere with the detection or management of suspected
             drug-related pulmonary toxicity; Or other moderate to severe lung diseases that
             seriously affect lung function;
         13. * Known history of primary immunodeficiency virus infection or positive HIV test;
         14. * Patients with chronic hepatitis B or HBV carriers of chronic hepatitis B virus
             (HBV), or patients with active hepatitis C should be excluded;
         15. * Any of the following cardiovascular diseases
               1. have evidence of acute or persistent episodes of myocardial ischemia;
               2. symptomatic pulmonary embolism is present;
               3. acute myocardial infarction occurred within 6 months prior to the initial study
                  treatment;
               4. symptomatic congestive heart failure (grade 3 or 4 according to the New York
                  Heart Association Functional Scale) occurred within 6 months prior to the first
                  study treatment;
               5. Occurrence of grade 2 or more ventricular arrhythmias within 6 months prior to
                  the first study treatment;
               6. cerebrovascular accident or transient ischemic stroke occurred within 6 months
                  prior to the first study treatment
         16. * Subjects with pleural effusion, pericardial effusion, or ascites that, in the
             investigator's judgment, cannot be stably controlled by repeated drainage or
             other methods;
         17. Have received a live vaccine within 30 days prior to the first dose or plan to receive
             a live vaccine during the study period;
         18. * Disease known to produce severe hypersensitivity to other monoclonal antibodies;
         19. Any condition that the investigator believes may result in a risk of acceptance of the
             study drug treatment or interfere with the evaluation of the study drug or the safety
             of the subjects or the interpretation of the study results;
         20. * With a second primary tumor (within 5 years).