PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer
NCT ID: NCT03081715
Last Updated: 2019-06-12
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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COMPLETED
NA
16 participants
INTERVENTIONAL
2017-03-14
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
PD-1 Knockout T Cells
Programmed cell death 1(PD-1) gene will be knocked out by CRISPR Cas9
Interventions
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PD-1 Knockout T Cells
Programmed cell death 1(PD-1) gene will be knocked out by CRISPR Cas9
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Anhui Kedgene Biotechnology Co.,Ltd
UNKNOWN
Hangzhou Cancer Hospital
OTHER
Responsible Party
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Shixiu Wu
Professor
Principal Investigators
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shixiu wu, Professor
Role: PRINCIPAL_INVESTIGATOR
Hangzhou Cancer Hospital
Locations
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Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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References
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Niu Y, Shen B, Cui Y, Chen Y, Wang J, Wang L, Kang Y, Zhao X, Si W, Li W, Xiang AP, Zhou J, Guo X, Bi Y, Si C, Hu B, Dong G, Wang H, Zhou Z, Li T, Tan T, Pu X, Wang F, Ji S, Zhou Q, Huang X, Ji W, Sha J. Generation of gene-modified cynomolgus monkey via Cas9/RNA-mediated gene targeting in one-cell embryos. Cell. 2014 Feb 13;156(4):836-43. doi: 10.1016/j.cell.2014.01.027. Epub 2014 Jan 30.
Rosenberg SA, Restifo NP. Adoptive cell transfer as personalized immunotherapy for human cancer. Science. 2015 Apr 3;348(6230):62-8. doi: 10.1126/science.aaa4967.
Sharma P, Allison JP. Immune checkpoint targeting in cancer therapy: toward combination strategies with curative potential. Cell. 2015 Apr 9;161(2):205-14. doi: 10.1016/j.cell.2015.03.030.
Other Identifiers
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HangzhouCH07
Identifier Type: -
Identifier Source: org_study_id
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