A Phase 1 interventional study of HEKT cell in Non Small Cell Lung Cancer, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Ruijin Hospital · Phase 1, Interventional, and Treatment
The purpose of this study to preliminarily evaluate the safety and efficacy of High Efficient Killing Cell Therapy for refractory and advanced non-small cell lung cancer
Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times.
Biological: HEKT cell
3 cycles of HEKT cell treatment
Also known as: High Efficient Killing Cell Therapy
safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment
Occurrence of study related adverse events as assessed by CTCAE v4.0
Time frame: 2 years
efficacy: complete response; partial response; stable disease; progression disease; progression free survival.
The efficacy of the treatment is assessed according to (RECIST1.1)
Time frame: 2 years
Progression free survival
Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause.
Time frame: 2 years
Overall survival
Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.
Time frame: 2 years
Imaging evaluation before and after treatment
the SUV index of PET-CT before cell injection and after the whole course of the treatment
Time frame: 0 day and 60 day
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Ruijin Hospital