PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer
Not Applicable
Completed
- Conditions
- Esophageal Cancer
- 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.
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
Hangzhou Cancer Hospital🇨🇳Hangzhou, Zhejiang, China