L-TIL in Patients With Malignancy Resistance to Anti-PD-1 Therapy

Study Overview
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Brief Summary
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Safety and effectiveness of liquid tumor infiltrating lymphocytes in patients with advanced malignant tumors who have failed to anti-PD-1 therapy

Official Title
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Clinical Study of Liquid Tumor Infiltrating Lymphocytes in Patients With Advanced Malignancies Resistance to Anti-PD-1 Therapy

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Biological: liquid tumor infiltrating lymphocytes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Expected lifespan is over 3 months malignant tumors diagnosed by pathological examination Imaging examination is at advanced stage with at least one measurable lesion Ineffective or resistant to previous anti-PD-1 therapy ECOG score 0-2 Adequate organ function No other serious diseases that conflict with this protocol Women of childbearing age must check for a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the test and within 3 months witten informed consent from the patients Exclusion Criteria: Severe infectious disease within 4 weeks before enrollment Active hepatitis B or C virus or HIV infection Severe autoimmune disease or immunodeficiency disease Severe allergies Severe mental disorder Systematically used a large amount of glucocorticoids within 4 weeks before enrollment With severe heart, liver, kidney insufficiency, diabetes and other diseases Participation in other clinical studies in the past 3 months or having been treated with other gene products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group 1<br>arm 1: secondary resistance to anti-PD-1 therapy: this patients group received liquid tumor infiltrating lymphocytes combined anti-PD-1 therapy. arm 2: primary resistance to anti-PD-1 therapy: this patients group received FC preconditioning before received liquid tumor infiltrating lymphocytes | Biological: liquid tumor infiltrating lymphocytes<br>* Isolatation and amplification PD-1+ cells from peripheral blood lymphocytes under GMP conditions for clinical use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of reverse events | the rate of reverse events | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical benefit rate | the proportion of patients benefit from liquid tumor infiltrating lymphocytes | three months | 
| time to progression | from the date of therapy to the first date of determined progressive disease | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liquid tumor-infiltrating lymphocytes, anti-PD-1, resistance, solid tumor