A study of lifileucel (tumor-infiltrating lymphocytes) in adults with advanced soft tissue sarcoma ('SARATOGA')
Participant must be ≥ 16 years of age at the time of signing the informed consent and assent.
Participants who are > 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
Participant must have a confirmed diagnosis of histologically confirmed unresectable or metastatic UPS (Cohort 1) or DDLPS (Cohort 2), with or without a well-differentiated component, who have received ≥ 1 and a maximum of 3 prior systemic therapies, including ≥ 1 anthracycline-based regimen.
Participant has demonstrated progressive disease on or after the last line of therapy.
Participant has symptomatic untreated brain metastases.
The participant has an ECOG performance status of ≥ 2, a need for urgent therapy due to rapidly progressive disease or tumor mass effect, or an estimated life expectancy of< 6 months.
Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation.
Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease [SCID] or AIDS).
Single group
Lifileucel
Biological/VaccineStudy intervention will begin with a tumor resection from which lifileucel will be generated. The lifileucel regimen consists of a preparative NMA-LD regimen (ie, cyclophosphamide with mesna followed by fludarabine), the lifileucel infusion, and an abbreviated course of aldesleukin (interleukin-2).
Objective Response Rate
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the IRC
Complete Response Rate
To evaluate the efficacy of lifileucel as measured by CR rate per RECIST v1.1 as assessed by the IRC
Duration of Response
To evaluate the efficacy of lifileucel as measured by DOR per RECIST v1.1 as assessed by the IRC
Disease Control Rate
To evaluate the efficacy of lifileucel as measured by DCR per RECIST v1.1 as assessed by the IRC
Progression-Free Survival
To evaluate the efficacy of lifileucel as measured by PFS per RECIST v1.1 as assessed by the IRC
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