Trial | NCT03081715  Report issue

Title

PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
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.
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.
Study Started
Mar 14
2017
Primary Completion
Jan 23
2018
Study Completion
Feb 28
2018
Last Update
Jun 12
2019

Other PD-1 Knockout T Cells

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

Experimental Group Experimental

Peripheral blood lymphocytes will be collected and Programmed cell death 1(PD-1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and reinfused back into patients. To avoid allergic reactions, 50 mg hydrocortisone was intravenously injected into the patient 30 min before cells infusion every time. Best supportive care was also provided for patients. A total of 1 to 10 x 10^9 PD-1 Knockout T cells will be infused each cycle. Patients continued receiving treatment unless they had unacceptable adverse effects, or progressive disease confirmed by CT or they withdrew consent.

Criteria 

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
No Results Posted