Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbelZeta Inc.
With
Nektar Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
