Study of High Efficient Killing Cell Therapy for Advanced NSCLC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03193567|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : March 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Biological: HEKT cell||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of High Efficient Killing Cell Therapy for Advanced Non Small Cell Lung Cancer|
|Actual Study Start Date :||September 14, 2017|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||May 1, 2022|
Experimental: HEKT cell
Enrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times.
Biological: HEKT cell
3 cycles of HEKT cell treatment
Other Name: High Efficient Killing Cell Therapy
- safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment [ Time Frame: 2 years ]Occurrence of study related adverse events as assessed by CTCAE v4.0
- efficacy: complete response; partial response; stable disease; progression disease; progression free survival. [ Time Frame: 2 years ]The efficacy of the treatment is assessed according to (RECIST1.1)
- Progression free survival [ Time Frame: 2 years ]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.
- Overall survival [ Time Frame: 2 years ]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.
- Imaging evaluation before and after treatment [ Time Frame: 0 day and 60 day ]the SUV index of PET-CT before cell injection and after the whole course of the treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193567
|Contact: Lei H Du, M.Sfirstname.lastname@example.org|
|Contact: Lei hai Du, Master|