C-TIL051 in Non-Small Cell Lung Cancer
Metastatic Non Small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Metastatic Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Previous treatment with PD1/PDL1 inhibitor for metastatic disease, Immune checkpoint blockade (ICB) given as part of definitive therapy for stage Ib-III disease with surgery or after chemo/radiation is acceptable if last dose of ICB is at least 6 months prior to enrollment in this study. Known driver mutations such as EGFR, ALK, ROS1, RET, METex14, and NTRK alterations. Current or prior use of any immunosuppressive medications within 14 days before tumor harvest Known active CNS metastases which are symptomatic History of leptomeningeal metastases Uncontrolled intercurrent illness Known history of HIV+ or AIDS, hepatitis C, acute or chronic active hepatitis B or other serious chronic infection Live vaccine within 30 days of tumor harvest History of allogeneic organ transplant History of primary immunodeficiency Hypersensitivity to anti-PD1 agent, cyclophosphamide, fludarabine, interleukin-2, gentamicin, or any excipient Any condition that may interfere with evaluation of study treatment, safety or study results Active infection that requires IV antibiotics within 7 days of tumor harvest Unresolved greater than grade 1 toxicity (CTCAE v5.0) from previous therapy History of interstitial pneumonitis of autoimmune etiology that is symptomatic or requires treatment Pulmonary disease history requiring escalating amounts of oxygen > 2L Known autoimmune conditions requiring systemic immune suppression therapy other than low dose prednisone or equivalent. Other malignancy, other than cutaneous localized) that required active treatment in the last 2 years. Women who are pregnant or lactating Women of childbearing potential or fertile men who are unwilling to use effective contraception during study and 6 months after treatment
Sites / Locations
- Duke Cancer Institute
Arms of the Study
Arm 1
Experimental
C-TIL051
C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab