C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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 TIL's could improve proliferation and persistence of cellular therapies leading to enhanced anti-tumor activity.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Able to understand and give written informed consent

• Histologically and cytologically confirmed diagnosis of stage IV or recurrent non-small cell lung cancer (NSCLC) with adenocarcinoma or squamous histology

• Planned for treatment with an anti-PD1 agent

• Tumor accessible by surgery, previously not irradiated and ≥ 1.5 cm in diameter

• Measurable disease after resection of tumor by RECIST 1.1

• ECOG ≤ 1

• Expected survival \> 6 months

• Adequate organ and marrow function

• ECHO, MUGA or cardiac stress test within past 6 months showing LVEF \>50% and without evidence of reversible ischemia

• Pulmonary function tests within past 6 months showing DLCO \>50% of predicted

Locations
United States
California
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Louisiana
Ochsner MD Anderson Cancer Center
RECRUITING
New Orleans
North Carolina
Duke Center for Cancer Immunotherapy
RECRUITING
Raleigh
Pennsylvania
Allegheny Health Network-West Penn Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Barbara Mittleman, MD
clinicaltrials@abelzeta.com
240-552-5870
Backup
Nurat Quadri, MS
clinicaltrials@abelzeta.com
240-552-5870
Time Frame
Start Date: 2024-02-29
Estimated Completion Date: 2027-08
Participants
Target number of participants: 20
Treatments
Experimental: C-TIL051
C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab
Sponsors
Leads: AbelZeta Inc.
Collaborators: Nektar Therapeutics

This content was sourced from clinicaltrials.gov