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Completed

NCT Number: NCT03081715

PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer

This study will evaluate the safety of PD-1 knockout engineered T cells in treating advanced esophageal cancer. Blood or tissue samples will also be collected for research purposes.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310002, China

About this study

This is a prospective clinical study of ex-vivo selected, engineered, and expanded PD-1 knockout T cells from autologous origin. 16 advanced esophageal cancer patients are planned to receive two cycles of PD-1 knockout engineered T cells infusion. Immunological markers are analyzed as well.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed recurrent or metastatic esophageal cancer
  • Measurable disease
  • Progressed after standard treatments
  • ECOG performance status of 0-2
  • Expected life span: >= 3 months
  • Toxicities from prior treatment has resolved or ≤ grade 1
  • Major organs function normally
  • Women at pregnant ages should be under contraception
  • Willing and able to provide informed consent

Exclusion criteria

  • Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ
  • Poor vasculature
  • Disease to the central nervous system
  • Blood-borne infectious disease, e.g. hepatitis B
  • History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
  • With other immune diseases, or chronic use of immunosuppressants or steroids
  • Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
  • Breastfeeding
  • Decision of unsuitableness by principal investigator or physician-in-charge

Treatment and study plan

PD-1 Knockout T Cells

Other

Programmed cell death 1(PD-1) gene will be knocked out by CRISPR Cas9

Primary outcomes

  1. Response Rate

    Time frame: 1-3 months

    Response will be evaluated according to RECIST v1.1

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: 6 months

    Number of participants with Adverse Events and grade as a measure of safety and tolerability of PD-1 knockout T cells using CTCAE v4.03

Other outcomes

  1. Progression free survival (PFS)

    Time frame: 1 year

    From date of randomization until the date of first documented progression or date of death from any cause

  2. Overall Survival (OS)

    Time frame: 1 year

    The time from randomization to death from any cause

  3. Peripheral blood T lymphocyte subsets

    Time frame: 6 weeks

    Sera were collected at baseline and after the first cycle to measure T lymphocyte subsets with flow cytometry

  4. Tumor-infiltrating T cells

    Time frame: Baseline and after treatment

    Baseline and post-treatment tissue samples were tested for the tumor-infiltrating T cells with immunofluorescence.

Sponsors and collaborators

Lead sponsor

Hangzhou Cancer Hospital

Other

Collaborators

  • Anhui Kedgene Biotechnology Co.,Ltd

Registry information

Official study title

Safety and Activity of Programmed Cell Death-1 Knockout Engineered T Cells in Patients With Previously Treated Advanced Esophageal Squamous Cell Carcinoma: An Open-label, Single-arm Phase 1 Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2017
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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