Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05676749
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2022-12-07
Brief Title:
C-TIL051 in Non-Small Cell Lung Cancer
Sponsor:
AbelZeta Inc
Organization:
AbelZeta Inc
Study Overview
Official Title:
C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this Phase 1 clinical study is test tumor infiltrating lymphocytes known as C-TIL051 with NKTR-255 and anti-PD1 therapy for subjects with refractory non-small cell lung cancer
The purpose of this study is to
1 Test the safety and ability for subjects to tolerate the TIL therapy
2 Measure to see how the NSCLC responds to the TIL therapy
Participants will be asked to
Provide a tumor sample prior to the start of any treatment which will be used to make the C-TIL051
Receive standard of care treatment until their lung cancer no longer responds
When necessary the C-TIL051 will be manufactured by the sponsor and sent back to the site
Subject will then receive chemotherapy called lymphodepletion for 3 days followed by 2 days of rest
C-TIL051 will then be infused on day 0 followed by NKTR-255 IL-15 about 12 to 24 hours later
Pembrolizumab will be administered every 3 weeks for up to 2 years
NKTR-255 is a novel polymer-conjugated human IL-15 receptor agonist molecule designed to increase the proliferation and survival of memory CD8 T cells and enhance the formation of long-term immunological memory which may lead to sustained anti-cancer immune response The combination of NKTR 255 and TILs could improve proliferation and persistence of cellular therapies leading to enhanced anti-tumor activity
The purpose of this study is to
1 Test the safety and ability for subjects to tolerate the TIL therapy
2 Measure to see how the NSCLC responds to the TIL therapy
Participants will be asked to
Provide a tumor sample prior to the start of any treatment which will be used to make the C-TIL051
Receive standard of care treatment until their lung cancer no longer responds
When necessary the C-TIL051 will be manufactured by the sponsor and sent back to the site
Subject will then receive chemotherapy called lymphodepletion for 3 days followed by 2 days of rest
C-TIL051 will then be infused on day 0 followed by NKTR-255 IL-15 about 12 to 24 hours later
Pembrolizumab will be administered every 3 weeks for up to 2 years
NKTR-255 is a novel polymer-conjugated human IL-15 receptor agonist molecule designed to increase the proliferation and survival of memory CD8 T cells and enhance the formation of long-term immunological memory which may lead to sustained anti-cancer immune response The combination of NKTR 255 and TILs could improve proliferation and persistence of cellular therapies leading to enhanced anti-tumor activity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None