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:
- Are diagnosed with NSCLC
- Have not received checkpoint inhibitor therapy
- Have tumor tissue that can be surgically removed
- Have never received treatment with a cellular therapy
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?
Description
If you choose to join this study, you will:
- Undergo surgery to collect your tumor tissue to make the study drug
- Receive lympho-depleting chemotherapy
- Take the study drugs
- Have physical exams and blood draws
- Have imaging scans (CT and/or MRI)
- Have heart tests (ECG)
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