Adoptive Cell Therapy With (LN-145) in Combination With Pembrolizumab in Treating Patients With Unresectable or Metastatic Transitional Cell Cancer Who Have Failed Cisplatin-Based Chemotherapy

Inclusion Criteria:

The subject must understand the requirements of the study and voluntarily sign the informed consent form (ICF)
All subjects must have a histologically confirmed unresectable TCC (including renal pelvis, ureters, urinary bladder, and urethra)
Failed one and only one line of cisplatin-based chemotherapy per FDA guidelines.
Subjects must have an area of tumor amenable to excisional biopsy for the generation of TIL separate from, and in addition to , a target lesion to be used for response assessment.Have at least one resectable lesion to generate TILs
At least one measurable target lesion as defined by RECIST version 1.1
An Eastern Cooperative Oncology Group (ECOG) performance status of =< 1
Estimated life expectancy of >= 6 months
Adequate bone marrow function
Adequate organ function
Subjects must be seronegative for the human immunodeficiency virus (HIV)
Recovered from all prior anticancer therapy-related AEs to grade 1 or less
Negative serum pregnancy test (female subjects of childbearing potential)
Subjects of childbearing potential must be willing to practice an approved method of birth control starting at the time of informed consent and for 12 months after the completion of the study treatment regimen
Must be able and willing to comply with the study visit schedule and protocol requirements including long-term follow-up

Exclusion Criteria:

Have had another primary malignancy within the previous 3 years (with the exception of carcinoma in situ of the breast, cervix, or localized prostate cancer and non-melanoma skin cancer that has been adequately treated)
Have received prior cell transfer therapy that included a nonmyeloablative or myeloablative chemotherapy regimen
Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody, or pathway-targeting agents
Chemotherapy or radiotherapy with projected completion within 4 weeks of initiating study treatment
Bisphosphonate therapy for symptomatic hypercalcemia
Have had treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks before initiation of study treatment
Active or prior documented autoimmune or inflammatory disorders
Subjects who have any form of human immondeficiency virus (HIV)infection
Have severe infections within 4 weeks before initiation of study treatment
Have received a live or attenuated vaccine within 28 days of the non-myeloablative lymphodepletion (NMA-LD regimen)

Subjects with a history of hypersensitivity reaction(s) to any component of the LN-145 therapy and/or the other study drugs

Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) >= 450 msec for males (and >= 470 msec for females) calculated from 3 electrocardiograms (ECGs) (within a 30-minute timeframe) or history of familiar long-QT syndrome
Subjects who have a left ventricular ejection fraction (LVEF) < 45% or who are New York Heart Association functional classification class II or higher
Serious illnesses or medical conditions, which would pose increased risk for study participation and/or compliance with the protocol
Known clinically significant liver disease
Have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of =< 60%
Subjects with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
Subjects who are pregnant or breastfeeding
Active infection including tuberculosis (TB), hepatitis B, hepatitis C, or human immunodeficiency virus
Treatment with any other investigational agent within 4 weeks before initiation of study treatment