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COMPLETEDPhase 1NCT02793856

PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer

This study will evaluate the safety of PD-1 knockout engineered T cells in treating metastatic non-small cell lung cancer. Blood samples will also be collected for research purposes.

Lead sponsor: Sichuan University•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Sichuan University

Collaborators

Chengdu MedGenCell, Co., Ltd.

This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1 knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Biomarkers and immunological markers are collected and analyzed as well.

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Pathologically verified stage IV non-small cell lung cancer with measurable lesions (On CT: longest diameter of tumoral lesion \>=10 mm, shorted diameter of lymph node \>=15 mm; measurable lesions should not have been irradiated)
•Progressed after all standard treatment
•Performance score: 0-1
•Expected life span: \>= 6 months
•Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy
•Major organs function normally
•Women at pregnant ages should be under contraception
•Willing and able to provide informed consent

Exclusion Criteria

•Pathology is mixed type
•Emergent treatment of tumor emergency is needed
•Poor vasculature
•Coagulopathy, or ongoing thrombolytics and/or anticoagulation
•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
•Compliance cannot be expected
•Other conditions requiring exclusion deemed by physician

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 12, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment12

Start dateAug 2016

Last updatedJan 12, 2021

Condition

Metastatic Non-small Cell Lung Cancer

Locations shown

West China Hospital, Sichuan University

Chengdu, Sichuan

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2021Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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