Advanced Solid Tumor
Conditions
Interventions
experimental group:neoantigen targeting T cells suspension for intravenous infusion
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Prior to HLA testing and de novo antigen testing, patients should be verified to meet the inclusion criteria with * (infectious disease testing is allowed at the same time as HLA typing) : 1.* Aged 18-75 years, no gender limit; 2.* Must have histologically or cytologically confirmed advanced solid tumors with at least one measurable tumor lesion (according to RECIST1.1 criteria); 3.HLA typing was HLA-A0201/1101/2402 (containing at least one of the types); 4. Paraffin-embedded tumor tissue/section or biopsy tumor tissue (biopsy is recommended for patients with easily sampled tumor lesions who consent to biopsy), which is qualified by gene sequencing data and qualified by neoplastic antigen screening; 5. Failure of systemic standard therapy or intolerance to standard therapy before enrollment, and meeting the following tumor species requirements: (1) Advanced solid tumors with positive de novo antigens (mainly advanced melanoma, non-small cell lung cancer, renal cell cancer) Advanced melanoma: second-line treatment failure; (2) Advanced non-small cell lung cancer: no driver gene, second-line treatment failure; (3) Advanced renal cell carcinoma: failure of second-line treatment; Note: The systemic standard treatment is recommended by the 2021 Guideline for the diagnosis and treatment of Melanoma, Non-small cell lung Cancer, and Kidney Cancer issued by the Chinese Society of Clinical Oncology. 6.* Volunteer to participate in clinical research; The patient or legal guardian was fully aware of the study and signed the informed consent; Willing to follow and complete all test procedures; 7.*ECOG score =6 months; 10. The patients are willing to use reliable methods of contraception during and within 3 months after the end of the treatment, and the blood pregnancy test of the women of reproductive age is negative; 11. The results of laboratory tests and the functions of vital organs meet the following requirements: (1) *HIV antibody negative; Treponema pallidum was negative; Negative for hepatitis C virus antibodies; The detection value of HBV DNA was lower than the upper limit of normal value. (2) Blood routine: neutrophil absolute value (ANC) >=1.5x10^9/L, white blood cell count (WBC) >=3x10^9/L, lymphocyte absolute value (LYM) >=0.8x10^9/L, platelet count (PLT) >=80x10^9/L, hemoglobin concentration (HGB) >=90g/L; (3) Blood biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =50%; 12. Before administration of lymphocyte clearance pretreatment: (1) Any chemotherapy, small-molecule targeted drugs, other investigational drugs, traditional Chinese medicine with antitumor indications, and other antitumor therapies received, have passed a 4-week washout period, and have recovered to grade 1 or lower toxicity (excluding hair loss, vitiligo, and other events deemed tolerable by the investigator); (2) Adverse reactions recovered to grade 1 or lower within 3 we
Exclusion criteria
Exclusion criteria: Before HLA testing and de novo antigen testing, subjects shall verify that they do not meet the exclusion criteria with * : 1.* Pregnant or lactating subjects; 2.* Has a history of severe hypersensitivity to the cells and any drugs used in this study; 3.* Subjects with a history of organ transplantation; 4. Subjects with known and clinically unstable CNS metastases, or subjects with acute meningitis (except those with clinically stable CNS metastases who have been treated for brain metastases); For clinical stability, at least 4 weeks before apheresis, (1) No new brain lesions or expansion of the original lesions (confirmed by MRI); (2) The subjects were not treated with hormone for at least 2 weeks; (3) No new neurological symptoms and the original neurological symptoms have returned to normal; 5.* Any subject with active autoimmune disease or a history of autoimmune disease that the investigator has determined to be ineligible for this study, including but not limited to: systemic lupus erythematosus (sle), immune related neuropathy, multiple sclerosis, guillain-barre syndrome, myasthenia gravis, connective tissue diseases, including crohn's disease and ulcerative colitis, inflammatory bowel disease (with the exception of vitiligo, eczema, subjects with type 1 diabetes, rheumatoid arthritis and other joint disease, subjects with sjogren's syndrome and use local drug control psoriasis); 6. Uncontrolled concomitant or infectious diseases, such as acute active infection requiring systemic antibiotic, antiviral, or antifungal therapy within 2 weeks before enrollment; 7. Has uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or medically poorly controlled hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >90mmHg), or clinically significant (e.g., active) cardiovascular and cerebrovascular disease, such as cerebrovascular accident (within 6 months before signing the informed consent), myocardial infarction (within 6 months before signing the informed consent), unstable angina, New York Heart Association (NYHA) class ? or higher congestive heart failure, serious arrhythmia cannot use drug control, electrocardiogram (ecg) in 3 consecutive (every time interval of at least 5 minutes) and clinical significance of abnormal results show that exist by researchers for determining influence subsequent cell therapy is unusual, or mental illness and substance abuse, researchers think that may increase the subjects or interfere with the test results of any dangerous situation; 8. Subjects were excluded if they were scheduled to receive glucocorticoids (prednisone or equivalent at a dose of >10mg/ day) or other immunosuppressive agents within 4 weeks prior to lymphocyte clearance pretreatment and during the study period due to certain conditions; Remarks: In the absence of active autoimmune disease, prednisone or an equivalent adrenal drug dose of 10mg or less per day may be used instead; Subjects were allowed to use topical, ocular, intra-articular, intranasal, and inhaled glucocorticoids (with minimal systemic absorption). 9. The subject is scheduled to receive immunomodulatory drugs (such as interferon, GM-CSF, thymosin, gamma globulin, interleukin, etc.) within 4 weeks before lymphocyte clearance pretreatment and during the study due to certain conditions; 10.* The investigator assessed that the subject could not comply with the study protocol; 11. Those with defects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Duration of response;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactChen Yu
Outcome results
None listed