C-TIL051 in Non-Small Cell Lung Cancer

Open to people ages 18 years and up

• 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

• 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