Purpose of this Study
We are doing this study to find out if the combination of 2 experimental drugs called C-TIL051 and NKTR-255 when they are given along with pembrolizumab is a safe and effective option for non-small cell lung cancer (NSCLC). C-TIL051 is custom-made for each participant from their own tumor tissue. Immune cells are isolated from your tumor tissue, regrown in a lab, and then formulated to be returned to your bloodstream. We want to know if C-TIL051 can help people's immune systems target and destroy cancer cells. NKTR-255 is designed to help C-TIL051 work better.
Who Can Participate?
Eligibility
Adults ages 18 or older who:
<ul>
<li>Are diagnosed with NSCLC</li>
<li>Have not received checkpoint inhibitor therapy</li>
<li>Have tumor tissue that can be surgically removed</li>
<li>Have never received treatment with a cellular therapy</li></ul>
For more information about who can join this study, please contact the study team at 919-681-6468.
<ul>
<li>Are diagnosed with NSCLC</li>
<li>Have not received checkpoint inhibitor therapy</li>
<li>Have tumor tissue that can be surgically removed</li>
<li>Have never received treatment with a cellular therapy</li></ul>
For more information about who can join this study, please contact the study team at 919-681-6468.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will:
<ul>
<li>Undergo surgery to collect your tumor tissue to make the study drug</li>
<li>Receive lympho-depleting chemotherapy</li>
<li>Take the study drugs</li>
<li>Have physical exams and blood draws</li>
<li>Have imaging scans (CT and/or MRI)</li>
<li>Have heart tests (ECG) </li></ul>
<ul>
<li>Undergo surgery to collect your tumor tissue to make the study drug</li>
<li>Receive lympho-depleting chemotherapy</li>
<li>Take the study drugs</li>
<li>Have physical exams and blood draws</li>
<li>Have imaging scans (CT and/or MRI)</li>
<li>Have heart tests (ECG) </li></ul>
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer
Principal Investigator
Jeffrey
Clarke
Protocol Number
PRO00112188
NCT ID
NCT05676749
Phase
I
Enrollment Status
Open to Enrollment