The study is to assess the safety and efficacy of the immunotherapies using anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells in the treatment of patients with advanced esophageal cancer.
This is a combined phase 1 and 2 clinical study. The aim of the study is to assess the safety and efficacy of the immunotherapies using anti- MUC1 CAR T cells alone, anti- MUC1 CAR T combining PD-1 knockout engineered T cells, and PD-1 knockout engineered T cell only in the treatment of patients with advanced esophageal cancer. The treatment outcomes from each group will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Using the T cells from the patients' blood to produce anti-MUC1 CAR-T Cells and then the cells will be infused back to the patients.
Using the T cells from the blood of the patients to prepare PD-1 knockout T cells, then the cells will be infused back to the patients.
Using the T cells from the blood of the patients to prepare anti-MUC1 CAR-T Cells and PD-1 knockout T cells, then the cells will be infused back to the patients
First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
RECRUITINGProfessor Size Chen
Guangzhou, Guangdong, China
RECRUITINGNumber of participants with adverse events and dose limiting toxicities as assessed by CTCAE v4.0
Safety and tolerability of dose of CART-cells and PD-1 Knockout T cells will be assessed using CTCAE v4.0.
Time frame: approximately 12 months
Response Rate
Will be assessed according to the revised RECIST guideline v1.1
Time frame: 12 months
Overall Survival - OS
Measure the time from enrollment to death
Time frame: Up to 24 months
Progression free survival - PFS
Time from enrollment to date of first documented progression or date of death.
Time frame: Up to 12 months
Median CAR-T cell persistence
Will be measured by quantitative RT-PCR
Time frame: 3 years
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