Non-small cell lung cancer, cervical cancer, melanoma
Conditions
Interventions
Experimental group:LM103 infusion
Sponsors
Tianjin Beichen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Stage III or IV patients with locally advanced or relapsed, metastatic cervical cancer, metastatic melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma and other solid tumors (confirmed histologically) that have progressed after surgery and standard chemotherapy. 2. Progress after molecular targeted drug therapy. 3. The interval between the first TIL treatment and the end of previous chemotherapy or investigational drug treatment should be more than 4 weeks. 4. The first TIL treatment should be more than 2 weeks removed from the end of previous radiotherapy or molecule-targeted drug therapy, include anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibitory T cell receptor (e.g. CTLA-4, OX-40, CD137), peptide /mRNA neoantigen immunotherapy, or other immunotherapy or cell therapy. 5. There was at least one measurable tumor lesion and the response was assessed according to the solid tumor response evaluation criteria RECIST1.1. 6. Aged >=18 years. 7. Expected survival time is more than 3 months. 8. The physical status of ECOG is 0 or 1. 9. Laboratory inspection indicators required: (1) Blood routine: lymphocyte ratio was greater than 20%, leukocyte > 3.0x10^9/L; (2) Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 1.5cm ^3) or biopsy puncture tissue (> 1.5cm ^3) can be obtained. 11. Able to follow research and follow-up procedures. 12. Understand and voluntarily sign informed consent to participate in clinical studies.
Exclusion criteria
Exclusion criteria: 1. Have an active, known or suspected autoimmune disease or other concurrent immune system disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, psoriasis, uncontrolled asthma, etc.). 2. Acute or chronic infectious diseases, active hepatitis such as hepatitis B or C; HIV antibody positive; Antibody positive for treponema pallidum. 3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 4. Have known, active, untreated CNS metastatic and/or cancerous meningitis. 5. Having a known mental illness or substance abuse disorder that interferes with compliance with research requirements. 6. Received systemic cytotoxic chemotherapy or other experimental drugs within one month. 7. Participated in or had participated in a study of any investigational drug within 30 days prior to screening, or had used the investigational device within 4 weeks prior to initial administration of the investigational drug. 8. Any disease, treatment, laboratory abnormalities, or medical history that may be confounding the results of the study or the participant's inability to participate in the study, or that the treatment investigator considers such subjects unsuitable for participation in the study. 9. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune response after treatment;Objective response rate;Disease control rate;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactLi Feng'e
Tianjin Beichen Hospital
Outcome results
None listed