PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer

Not Applicable

Completed

• Conditions: Esophageal Cancer
• Interventions: Other: PD-1 Knockout T Cells

• Registration Number: NCT03081715
• Lead Sponsor: Hangzhou Cancer Hospital

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-11
• Study First Submitted QC: 2017-03-11
• Study Start: 2017-03-14
• Study First Posted: 2017-03-16
• Primary Completion: 2018-01-23
• Study Completion: 2018-02-28
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-10
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	PD-1 Knockout T Cells	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.

Primary Outcome Measures

Name	Time	Method
Response Rate	1-3 months	Response will be evaluated according to RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	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

Trial Locations

Locations (1)

Hangzhou Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China