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

June 10, 2020 updated by: Henan Cancer Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible patients in our hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Biological: liquid tumor infiltrating lymphocytes
Isolatation and amplification PD-1+ cells from peripheral blood lymphocytes under GMP conditions for clinical use.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2020

Primary Completion (Anticipated)

February 19, 2022

Study Completion (Anticipated)

June 19, 2022

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Liquid TIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Need to solicit patients' consent whether to agree to share their information during the enrollment process,

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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