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

NCT ID: NCT04268108

Last Updated: 2020-06-11

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-02

Study Completion Date

2022-06-19

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

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Quanli Gao, Dr.

Role: CONTACT

+86-371-65587795

Tiepeng Li, Dr.

Role: CONTACT

+86-371-65587199

Facility Contacts

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Quanli Gao, M.D

Role: primary

+86-371-65587795

Lingdi Zhao, M.D.

Role: backup

+86-371-65587483

Other Identifiers

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Liquid TIL

Identifier Type: -

Identifier Source: org_study_id

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