C-TIL051 in Non-Small Cell Lung Cancer

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