Phase
Condition
Carcinoma
Treatment
Fludarabine
Biospecimen Collection
Antineoplastic Immune Cell
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented informed consent of the participant and/or legally authorizedrepresentative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) 0 or 1
Lung non-small cell carcinoma (NSCLC) patients with advanced, metastatic, orrecurrent disease, previously treated with a PD-1 or PD-L1 immune checkpointinhibitor, either as single agent or in combination with chemotherapy or otherimmunotherapy or experimental agents
Radiographically demonstrable tumor progression treatment on or after therapy with aPD-1/PD-L1 immune checkpoint inhibitor
Preserved organ function and recovery of prior drug related toxicities (exceptalopecia or grade 2 anemia) to grade 1 or better
No cytotoxic chemotherapy or immunotherapy over the three weeks prior tolymphodepletion
Histologically confirmed non-small cell lung cancer
Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST)criteria 1.1
Fully recovered from the acute toxic effects (except alopecia) to =< grade 1 toprior anti-cancer therapy
Absolute neutrophil count (ANC) >= 1,500/mm^3
Hemoglobin (Hgb) >= 8 g/dl
Platelets >= 100,000/mm^3
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) =< 1.5 x ULN
Alanine aminotransferase (ALT) =< 1.5 x ULN
Alkaline phosphatase (AP) =< 1.5 x ULN
Creatinine clearance of >= 60 mL/min per 24-hour urine test or the Cockcroft-Gaultformula
If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) =< 1.5 x ULN
If on anticoagulant therapy: PT must be within therapeutic range of intended use ofanticoagulants
Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab)combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigennegative)
If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed
Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. Ifthe urine test is positive or cannot be confirmed as negative, a serum pregnancytest will be required
Agreement by females and males of childbearing potential to use an effective methodof birth control or abstain from heterosexual activity for the course of the studythrough at least 06 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men andwomen) or have not been free from menses for > 1 year (women only)
Exclusion
Exclusion Criteria:
Autologous stem cell transplant within 1 year prior to day 1 of protocol therapy
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 daysprior to day 1 of protocol therapy
History of allergic reactions attributed to compounds of similar chemical orbiologic composition to study agent
Active diarrhea
Clinically significant uncontrolled illness
Active infection requiring antibiotics
Known history and/or positive serology for immunodeficiency virus (HIV) or hepatitisB or hepatitis C infection
Diagnosis of Gilbert's disease
Other active malignancy
Females only: Pregnant or breastfeeding
Severe (grade 3 or higher) immune related adverse events during prior PD-1 inhibitortreatment
Any other condition that would, in the Investigator's judgment, contraindicate thepatient's participation in the clinical study due to safety concerns with clinicalstudy procedures
Concomitant use of other investigational agents
Patients with EGFR mutations or ALK translocations in their tumors, unless treatmentwith the indicated tyrosine kinase inhibitor has failed
Active brain metastases. Previously treated brain metastasis must demonstratestability on subsequent magnetic resonance imaging (MRI) scans
Prospective participants who, in the opinion of the investigator, may not be able tocomply with all study procedures (including compliance issues related tofeasibility/logistics)
Study Design
Study Description
Connect with a study center
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United StatesActive - Recruiting
City of Hope Medical Center
Duarte, California 91010
United StatesSite Not Available
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange 5379513, California 5332921 92868
United StatesSite Not Available

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