Lung Cancer Clinical Trial
C-TIL051 in Non-Small Cell Lung Cancer
Summary
The goal of this Phase 1 clinical study is test tumor infiltrating lymphocytes (known as C-TIL051) with anti-PD1 therapy for subjects with refractory non-small cell lung cancer.
The purpose of this study is to:
Test the safety and ability for subjects to tolerate the TIL therapy
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 interleukin-2
Pembrolizumab will be administered every 3 weeks for up to 2 years
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, KRAS G12C, ALK, ROS1, BRAF V600E, RET, METex14, and NTRK alternations.
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
QTc ≥ 470 ms
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 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 unwilling to use effective contraception during study and 6 months after treatment
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There is 1 Location for this study
Raleigh North Carolina, 27710, United States More Info
Principal Investigator
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