Lung Cancer
Conditions
Interventions
Case series:The self PD-1 deletion gene T lymphocytes treatment
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-70 years men and women; (2) ST-glycosylated MUC-1 expression =1+ was determined by immunohistochemistry (IHC) in a laboratory approved by the bid party; (3) advanced lung cancer patients diagnosed by pathology; (4) Patients with recurrent or metastatic lung cancer who have not received systemic chemotherapy before, except for neoadjuvant chemotherapy, concurrent chemoradiotherapy or adjuvant chemotherapy received 6 months prior to the first dose; (5) PD-L1 tumor antigen expression >50% or tumor tissue MSI-H or tumor mutation load >5Mb in tumor tissue samples diagnosed as lung cancer; (6) No chemotherapy, radiotherapy, molecular targeted therapy, Chinese medicine treatment, and surgery were performed within 4 weeks before the start of the study, and had recovered from the acute toxicity of the previous treatment, with the exception of alopecia and peripheral nerve toxicity; (7) The serum calcium, potassium and magnesium levels are within the standard range; (8) ECOG performance status score 0-1; (9) Expected survival period = 12 weeks; (10) Measurable lesions that meet the RECIST v1.1 criteria; (11) The blood test standard for one week prior to treatment is in line with (any blood component and cell growth factor are not allowed within 14 days before screening): HB =90g/L (without transfusion in 14 days), ANC =1.5× 10^9/L, PLT =80×10^9/L, lymphocyte (LY) = 0.7×10^9/L, LY% =15%, Alb =2.8g/dL, serum lipase and amylase 50 ml/min (Cockcroft-Gault formula); vital organ function is normal: cardiac ultrasound prompts cardiac ejection fraction = 50%, no abnormal electrocardiogram; blood oxygen saturation =90%; (12) No hemorrhagic disease or coagulopathy; (13) does not produce allergy to the developer; (14) Non-surgical sterilisation or women of childbearing age require a medically approved contraceptive measure (such as an intrauterine device [IUD], contraceptive pill or contraception during the study period and within 3 months of the end of the study treatment period). Female patients of childbearing age who have undergone non-surgical sterilization must be negative for serum or urine HCG within 7 days prior to enrollment; and must be non-lactating; women who have undergone sterilization or postmenopausal for at least 2 years can be identified as Does not have fertility; (15) Subjects voluntarily participated in this study and signed informed consent with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: (1) Unable to understand the purpose of research and/or agreement procedures; (2) Patients' T cells could not be amplified in pre-amplification experiments; (3) Patients who have received anti-PD-1, PD-L1, or CTLA-4 therapy; (4) Subjects with any history of active autoimmune disease or autoimmune disease (such as but not limited to: interstitial pneumonia, uveitis, colitis, hepatitis, pituitary inflammatory disease, vasculitis, nephritis, thyroid gland hyperthyroidism, lower thyroid function; subjects suffering from vitiligo or asthma had complete remission in childhood, adulthood without any intervention can be included; bronchodilators subject in need of medical intervention carried asthma is not included); (5) Subjects are using immunosuppressive agents, or systemic, or absorbable, topical hormone therapy to achieve immunosuppressive purposes (dose> 10 mg/day prednisone or other therapeutic hormone) and 2 weeks prior to enrollment It is still in use; (6) Known subjects were previously allergic to macromolecular protein preparations or known to have any related ingredients; (7) The subject has clinical symptoms of central nervous system metastasis (such as cerebral edema, hormone intervention, or brain metastasis progression); (8) Subjects had previous or simultaneous malignancy (other than cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); (9) Unsatisfactory cardiac clinical symptoms or diseases, such as: 1) NYHA class 2 or higher heart failure 2) Unstable angina 3) Myocardial infarction within 1 year 4) Clinically significant supraventricular or ventricular Arrhythmia patients who need treatment or intervention; (10) Wounds or fractures of the chest or other parts of the body that have not been healed for a long period of time; (11) Subjects with active infections or unexplained fever >38.5 degrees during the screening period and before the first dose (when the investigator determined that the subjects had fever due to tumors can be enrolled); (12) Subjects with congenital or acquired immunodeficiency (such as HIV-infected persons) or active hepatitis (HBsAg: Anti-HBs, Anti-HBs, HBeAg, Anti-HBc, Anti-HBe, HBV DNA =103/ml, Hepatocyte transaminase; Hepatitis C reference: HCV antibody and HCV RNA); (13) Subjects are known to have a history of psychotropic substance abuse, alcohol abuse, or drug abuse; (14) pregnant and lactating women; (15) participate in the treatment of another clinical study before the start of treatment and within 30 days before the start of the study; (16) judged by the investigator, there are other factors that could cause subjects of this study were forced to terminate the middle, like other serious diseases (including mental illness) requires combination therapy, there is a serious laboratory abnormalities, accompanied by family or Factors such as society may affect the safety of the subject or the collection of test data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No progres lifetime; | — |
Countries
China
Contacts
Public ContactLu Liqin
Zhejiang Provincial People's Hospital
Outcome results
None listed