solid tumor
Conditions
Interventions
Group 1:TEc injection
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with age >= 18 years and = 3 months; 3. Patients who have a physical condition score of 0 to 1 according to ECOG; 4. Archived tumor tissue or newly obtained biopsy tissue samples can be provided (at least 5 formalin-fixed paraffin-embedded tissue blocks or at least 10 unstained fresh sections); 5. Patients with pathologically confirmed malignant solid tumors include lung cancer, breast cancer, cervical cancer, digestive tract tumor, urinary system tumor, pancreatic cancer, biliary system tumor, etc. They have failed at least first-line standard treatment in the past, or have disease progression after systematic treatment, or are intolerant during treatment, or are currently inappropriate to receive standard treatment at this stage. And positive Trop2 staining rate by IHC is = 50% in the tumor tissue (for breast cancer only, enrollment does not rely on this result); 6. Patients who voluntarily receive peripheral blood mononuclear cell collection for cell preparation; 7. At least one or more measurable lesions (CT slice thickness = 5 mm, maximal diameter = 10 mm, and lymph node with malignant metastasis minimal diameter of =15 mm) according by RECIST 1.1; 8. No serious hematological, hepatic, and renal function abnormalities, adequate function defined as: Blood system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days): Neutrophil count (ANC) >= 1.5 × 10^9 / L; Platelet count (PLT) >= 75 × 10^9 / L; Hemoglobin (HB) >= 80g / L; Lymphocyte count (LYM) = 60% of the lower limit of normal value. Liver and renal function: Total bilirubin (TBIL) = 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST): = 2.5 × ULN (liver metastasis patients: = 5 × ULN); creatinine = 1.5 × ULN. Coagulation function: activated partial thromboplastin time (APTT) = 1.5 × ULN; International Standardized Ratio (INR) = 1.5 × ULN. 9. Eligible subjects (male or female ) must comply with effective contraception methods (hormonal or barrier method or abstinence, etc.) during the trial period at least 90 days after TEc injection; Female subjects of childbearing potential (definition refers to appendix) must undergo a pregnancy test (blood or urine) and the results must be negative within 7 days prior to first use of TEc injection. 10. Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with symptomatic and/or untreated brain metastases (of any size and number); However, subjects may be eligible if they received documented treatment, and the intractanial lesion(s) remain stable for at least 14 days before screening; 2 Subjects suffered from other malignant tumors or concurrent malignancy within two years prior screening, except for basal cell skin cancer that has been cured, and in situ malignancies of cervical carcinoma or lung cancer; 3. Subjects received treatment with tirelizumab (excluding other PD-1 monoclonal antibodies) or any PD-L1 monoclonal antibody within 12 weeks; 4. Subjects received systemic chemotherapy, radiotherapy, immunotherapy and targeted therapy within 2 weeks before screening; However, the restrtiction for Nitroso urea or Mitomycin C are within 6 weeks before screening; 5. Subjects received chronic systemic sex hormone treatment for any reason within 12 weeks before screening; However, the use of low-dose glucocorticoid replacement therapy due to adrenal cortex dysfunction is exempted. 6. Subjects received granulocyte Colony-stimulating factor (G-CSF) and Granulocyte-macrophage colony-stimulating factor (GM-CSF) for leukotherapy within 12 weeks before screening; 7. Subjects recived with TROP 2-targeted drug treatment previously; 8. Any active autoimmune disease or autoimmune disease in history, which is included but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; and asthma requiring medical intervention by bronchiectasis, etc., except for vitiligo, psoriasis and alopecia without systemic treatment, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement therapy; 9. Recipients of any organ transplant, including allogeneic stem cell transplants, with exception of transplants requiring no immunosuppression (e.g, corneal transplants, hair transplants); 10. Subjects with any forms of primary immunedeficiency (e.g, severe combined immunodeficiency disease [SCID] and acquired immunodeficiency syndrome [AIDS]) 11. Presence of major acute or chronic infections, including: ? Viral hepatitis, including hepatitis B (HBsAg positive and/or hepatitis B DNA copy number higher than the lower detection threshold of the research center), Hepatitis C, etc; HIV antibody test positive; Patients with positive Treponema pallidum antibodies; ? Active bacterial or fungal infections that require systemic treatment; ? Active tuberculosis infection withclinical symptoms, physical examination or imaging, and laboratory findings; 12. Acute exacerbation of chronic obstructive pulmonary disease or other respiratory diseases; 13. Cardiovascular/Cerebrovascular disease with clinical significance, such as cerebrovascular accident/stroke (300mg/d or clopidogrel>75mg/d, etc.); 18. Pregnant or lactating women; 19. Subjects with no/limited capacity for civil conduction, or mental disorders/ poor compliance; 20. Alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Progression-free survival;Duration of response; | — |
Countries
China
Contacts
Public ContactYi Zhang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed