L-TIL in Patients With Malignancy Resistance to Anti-PD-1 Therapy
NCT ID: NCT04268108
Last Updated: 2020-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2020-04-02
2022-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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group 1
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
liquid tumor infiltrating lymphocytes
Isolatation and amplification PD-1+ cells from peripheral blood lymphocytes under GMP conditions for clinical use.
Interventions
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liquid tumor infiltrating lymphocytes
Isolatation and amplification PD-1+ cells from peripheral blood lymphocytes under GMP conditions for clinical use.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Locations
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Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Liquid TIL
Identifier Type: -
Identifier Source: org_study_id
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