Melanoma
Conditions
Interventions
Dose-escalation group:Super circulating tumour infiltrating lymphocytes
Dose-expansion group :Super circulating tumour infiltrating lymphocytes
Sponsors
Beijing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 70 years; 2. Patients with expected natural survival >= 3 months; 3. Patients with acral and mucosal melanoma confirmed by histology or cytology; 4. Patients who have at least received the first-line system treatment before and who have developed intolerance during the course of disease progression or treatment; intolerance includes the following situations: (1) The function of the main organs of the subjects could not be restored after drug treatment according to the judgment of the researchers; (2) The subjects had grade 3 non hematologic toxicity or grade 4 hematologic toxicity (grade 3 thrombocytopenia) during the treatment; (3) Subjects rejected the optional first-line treatment; 5. The proportion of PD1 positive T cells in total T cells was >= 18%. The proportion of PD1 positive T cells in total T cells was >= 12% in patients who had just finished the treatment of PD1 monoclonal antibody before screening; 6. According to recist1.1, at least one patient with measurable lesions revealed by CT or MRI (the definition of measurable lesions is that under the condition that the scanning thickness is not more than 5.0mm, the longest diameter of tumor lesions is >= 10 mm, and the shortest diameter of metastatic lymph nodes is >= 15 mm); 7. Patients with ECoG score of 0-1; 8. Patients without serious hematology, liver and kidney function abnormalities meet the following laboratory test results: (1) Hematology: neutrophil >= 1.5x10^9/L, platelet >= 75x10^9/L, hemoglobin >= 90g/L, lymphocyte absolute value >=5 ULN; (2) Liver function: ALT and AST = 3.0g/dl; 9. At the beginning of screening, patients with washout period >= 4 weeks after anti-cancer treatment (chemotherapy and glucocorticoid). Glucocorticoids include hydrocortisone, prednisone, prednisolone, methylprednisolone, etc. Palliative radiotherapy is permissible as long as it does not involve the selection of lesions for til or as target or non target lesions. 10. male or fertile female subjects take effective contraceptive measures during the treatment and within 90 days after the last use of the drug; 11. Subjects who can follow the clinical research plan and follow-up procedure; 12. Subjects who can understand the research program and are willing to participate in the study and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with uveal / ocular melanoma; 2. Patients with symptomatic and / or untreated brain metastases (any size and number) may be included in the group; 3. Patients with another primary malignant tumor (breast, cervical or bladder carcinoma in situ, local prostate cancer) in the past 3 years; 4. Patients with any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma requiring medical intervention of bronchodilator for subjects cannot be included); however, the following patients are allowed to be included in the group: (1) Vitiligo, psoriasis and alopecia without systemic treatment; (2) Well controlled type I diabetes; (3) Hypothyroidism with normal thyroid function was treated by replacement therapy; 5. Patients receiving chronic systemic steroid therapy for any reason, except for the use of low-dose glucocorticoid replacement therapy due to adrenal insufficiency. 6. Patients receiving any organ transplantation, including allogeneic stem cell transplantation, except for transplantation without immunosuppression (such as corneal transplantation, hair transplantation); 7. Patients with any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease [SCID] and acquired immunodeficiency syndrome [AIDS]); 8. Patients with significant acute or chronic infections, including: (1) Known positive history of human immunodeficiency virus (HIV) test or known history of acquired immunodeficiency syndrome (not required for screening), if the researchers strongly doubt that. The subjects without known history of HIV infection, according to the local Standard Guide to the subjects of HIV testing knowledge); (2) Active TB infection (based on clinical symptoms, physical examination and / or imaging, and laboratory findings); (3) Active bacterial or fungal infections requiring systemic treatment; (4) Viral hepatitis, including hepatitis B and C; (5) Treponema pallidum antibody positive patients; 9. Patients hospitalized or suffering from acute exacerbation of COPD or other respiratory diseases that hinder the study and treatment within 30 days before admission; 10. Patients with clinically significant cardiovascular / cerebrovascular diseases, such as cerebrovascular accident / stroke (before enrollment = New York Heart Association grade II) or severe gravity disorder; 11. Patients who cannot tolerate CT or MRI contrast agent and / or are allergic to contrast agent; 12. Patients who participated in other clinical trials within 4 weeks; 13. Pregnant or lactating women; 14. Patients with a 2-year history of alcohol or drug abuse (known through questioning and past medical history); 15. Patients with other severe acute and chronic diseases, or patients without or limited capacity for civil conduct; 16. Patients or family members could not understand the contents and objectives of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR;DOR;PFS;OS;Detection of Lentivirus Copy Number;vital signs;Physical examination;Adverse events; | — |
Countries
China
Contacts
Public ContactJun Guo
Beijing University Cancer Hospital
Outcome results
None listed