The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.
Participants must have a histologically confirmed diagnosis of endometrial carcinoma. All histologies, including carcinosarcoma, will be allowed. Uterine sarcoma will not be allowed.
At least 1 but no more than 4 lines of prior systemic therapy with no more than 2 lines of chemotherapy in any setting (ie, neoadjuvant or adjuvant setting as well as for recurrent, metastatic, or primary unresectable disease. .
Participants have received platinum-based chemotherapy and anti-PD-1/PD-L1 therapy.
Participants who declined platinum-based chemotherapy regimen and/or an anti-PD-1/PD-L1 therapy or were deemed ineligible for such therapies by the investigator may be considered after discussion with the medical monitor.
Participants who have symptomatic untreated brain metastases.
Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
Participants who require systemic steroid therapy > 10 mg/day prednisone or another steroid equivalent dose.
Participants who have any form of primary immunodeficiency.
Single group
Lifileucel
Biological/VaccineA tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with lifileucel, followed by IL-2.
Objective Response Rate
To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.
Complete Response Rate
To evaluate the proportion of participants who have a confirmed complete response (CR) per RECIST v1.1.
Duration of Response
To measure from the first time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1.
Disease Control Rate
To measure by the percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) at any time or stable disease (SD) for at least 4 weeks per RICIST v1.1.
Progression-Free Survival
To evaluate the time from the date of the lifileucel infusion until disease progression per RECIST v1.1.
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