PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03081715|
Recruitment Status : Completed
First Posted : March 16, 2017
Last Update Posted : June 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Other: PD-1 Knockout T Cells||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||March 14, 2017|
|Actual Primary Completion Date :||January 23, 2018|
|Actual Study Completion Date :||February 28, 2018|
Experimental: Experimental Group
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.
Other: PD-1 Knockout T Cells
Programmed cell death 1(PD-1) gene will be knocked out by CRISPR Cas9
- Response Rate [ Time Frame: 1-3 months ]Response will be evaluated according to RECIST v1.1
- 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
- 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
- Overall Survival (OS) [ Time Frame: 1 year ]The time from randomization to death from any cause
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081715
|Hangzhou Cancer Hospital|
|Hangzhou, Zhejiang, China, 310002|
|Principal Investigator:||shixiu wu, Professor||Hangzhou Cancer Hospital|