18 Years and up
Accepting Healthy Volunteers?
To be eligible for the study, patients must meet ALL of the following criteria prior to
1. Must be ≥ 18 years of age at the time of consent
2. Must have recurrent, metastatic, or persistent squamous cell carcinoma, adenosquamous
carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment
with surgery and/or radiation therapy
3. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm
in diameter post resection to generate TIL; surgical removal with minimal morbidity
(defined as any procedure for which expected hospitalization is ≤ 3 days)
4. At least one measurable target lesion, as defined by RECIST v1.1
5. Must have had at least one and no more than three prior systemic chemotherapeutic
treatments (such as carboplatin/cisplatin, paclitaxel, and bevacizumab except where
there are contraindications) for cervical carcinoma
6. Any prior therapy directed at the malignant tumor must be discontinued at least 28
days prior to tumor resection. Radiation therapy may have been received up to 28 days
prior to tumor resection for lesions not expected to be used for TIL generation or
7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8. Patients must be seronegative for the human immunodeficiency virus (HIV). Patients
with positive serology for hepatitis B virus surface antigen (HBsAg), hepatitis B core
antibody (anti-HBc), or hepatitis C virus antibody (HCV Ab) indicating acute or
chronic infection may be enrolled if the viral load by polymerase chain reaction (PCR)
is undetectable with/without active treatment.
9. Patients of childbearing potential must be willing to take the appropriate precaution
to avoid pregnancy for the duration of the study and practice an approved, highly
effective method of birth control during treatment and for 12 months after receiving
the last protocol-related therapy.
10. Prior to study Enrollment (tumor resection), patient must have documentation of
radiological disease progression after the most recent therapy.
1. Patients who have received an organ allograft or prior cell transfer therapy except
for prior LN-145 therapy.
2. Patients who are on chronic systemic steroid therapy
3. Patients who currently have prior therapy-related toxicities > Grade 1 according to
National Cancer Institute (NCI-) Common Terminology Criteria for Adverse Events
(CTCAE) v4.03; except for peripheral neuropathy, alopecia, or vitiligo prior to
Enrollment (tumor resection)
4. Patients who have a history of hypersensitivity to any component or excipient of
LN-145 or other study drugs:
• NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)
5. Patients who have active systemic infections, coagulation disorders or other active
major medical illnesse(es) of the cardiovascular, respiratory, or immune system,
including evidence in the medical history of urinary tract obstruction, a positive
cardiac stress test, myocardial infarction, cardiac arrhythmia, obstructive or
restrictive pulmonary disease, or other conditions that in the opinion of the
Investigator would increase the risk of participation
6. Patients with symptomatic and/or untreated brain metastases (of any size and any
• Patients with definitively treated brain metastases may be considered for
Enrollment, and must be stable for ≥ 14 days prior to beginning the NMA-LD
7. Patients who have any form of primary immunodeficiency (such as severe combined
immunodeficiency [SCID] or acquired immunodeficiency syndrome [AIDS])
8. Patients who have a diagnosis of end-stage renal disorder requiring hemodialysis.
9. Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New
York Heart Association (NYHA) Class 2 or higher.
10. Patients who have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60%
11. Patients who have received a live or attenuated vaccine within 28 days prior to
beginning NMA-LD preconditioning regimen.
12. Patients whose cancer requires immediate attention or who would otherwise suffer a
disadvantage by participating in this study
13. Patients who have received prior treatment with immunotherapy (eg, anti-programmed
cell death protein-1 [PD-1], anti-programmed death ligand 1 [PD-L1], or anti-cytotoxic
T lymphocyte-associated antigen-4 [CTLA-4] antibodies)
14. Patients who have had another primary malignancy within the previous 3 years (except
for curatively treated localized malignancy that has not required treatment for > 1
year, and in the judgement of the Investigator, does not pose a significant risk of
recurrence including, but not limited to, non-melanoma skin cancer or bladder cancer)
15. Patients who have ≥ Grade 2 hemorrhage within 14 days prior to Enrollment (tumor