CAR T and PD-1 Knockout Engineered T Cells for Esophageal Cancer
NCT ID: NCT03706326
Last Updated: 2018-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2018-09-28
2021-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment with Anti-MUC1 CAR-T cells
Anti-MUC1 CAR-T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients.
Anti-MUC1 CAR-T cells
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.
Combination Therapy: CAR-T combining PD-1 knockout T Cells
Anti-MUC1 CAR-T cells and PD-1 knockout Engineered T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients.
CAR-T combined with PD-1 Knockout T cells
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
Treatment with PD-1 knockout Engineered T cells
PD-1 knockout Engineered T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients.
PD-1 knockout Engineered T cells
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.
Interventions
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Anti-MUC1 CAR-T cells
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.
PD-1 knockout Engineered T cells
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.
CAR-T combined with PD-1 Knockout T cells
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
Eligibility Criteria
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Inclusion Criteria
* MUC1 is highly expressed in malignancy tissues by immuno-histochemical (IHC).
* Eastern cooperative oncology group (ECOG) performance status of 0-1 or karnofsky performance status (KPS) score is higher than 60.
* Patients have a life expectancy \> 12 weeks.
* Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
* Negative pregnancy test for females of child-bearing potentials.
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
* Signed informed consent form.
Exclusion Criteria
* Patients with symptomatic central nervous system (CNS) involvement.
* Pregnant or nursing women.
* Known HIV, HBV and HCV infection.
* Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
* History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Previously treatment with any gene therapy products.
* The existence of unstable or active ulcers or gastrointestinal bleeding. Patients with portal vein vascular invasion or extrahepatic, are excluded from this study.
* Patients with a history of organ transplantation or are waiting for organ transplantation.
18 Years
80 Years
ALL
No
Sponsors
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Guangzhou Anjie Biomedical Technology Co., Ltd.
INDUSTRY
The First Affiliated Hospital of Guangdong Pharmaceutical University
OTHER
Responsible Party
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Size Chen
Associate Professor
Locations
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First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Professor Size Chen
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-6301
Identifier Type: -
Identifier Source: org_study_id
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