SarcomaPhase 2'SARATOGA'NCT07741877
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Soft Tissue Sarcoma
A Phase 2 study testing Lifileucel in people with Sarcoma and Soft Tissue Sarcoma (STS), run by Iovance Biotherapeutics, Inc. at 2 sites in United States.
Trial summary
A study of lifileucel (tumor-infiltrating lymphocytes) in adults with advanced soft tissue sarcoma ('SARATOGA') Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Sarcoma, Soft Tissue Sarcoma (STS), Advanced Soft Tissue Sarcoma
- What is being tested?
- Lifileucel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Oct 2026to 1 Sep 2034
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 is assessed as having at least one resectable lesion (or aggregate lesions) with an estimated minimum diameter of 1.5 cm (short axis) for lifileucel generation.
- Following tumor resection for lifileucel generation, the participant will have at least one measurable lesion, as defined by RECIST v1.1 at Baseline.
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- Participant is expected to achieve washout from investigational or anticancer therapy(ies).
- If the participant has preplanned surgical procedure(s), the procedure will take place at least 14 days (for major operative procedures) prior to the tumor resection. Wound healing will have occurred, and all complications will have resolved at the time of tumor resection.
- Participant has recovered from all prior anticancer treatment-related AEs to Grade ≤ 1(per NCI-CTCAE), except for peripheral neuropathy, alopecia, or vitiligo.
- Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
- Participants must have adequate organ function.
- Participant is willing to receive optimal supportive care, including intensive care, from enrollment until the first post-treatment tumor assessment.
Who cannot join
- 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).
- Participant has a history of hypersensitivity to any component of the study intervention.
- Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or have been curatively treated > 1 year ago, and in the judgment of the investigator does not pose a significant risk of recurrence.
- Other protocol defined inclusion/exclusion criteria could apply.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Soft Tissue Sarcoma
A study of lifileucel (tumor-infiltrating lymphocytes) in adults with advanced soft tissue sarcoma ('SARATOGA')
Read the detailed description
The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated soft tissue sarcoma. The length of the study for each participant may be up to 5 calendar years after receiving lifileucel. After Screening, each participant will have surgery to remove some tumor pieces that will be used to make the lifileucel, followed by a baseline visit prior to study treatment. Participants will then receive the lifileucel treatment regimen. This includes 2 drugs (cyclophosphamide and fludarabine) for up to 5 days to decrease lymphocytes in the body, the lifileucel infusion (1 day), and up to 4 days of aldesleukin to boost the activity of the lifileucel. Study visits will be every 6 weeks for 6 months, then every 3 months until 5 calendar years after the lifileucel infusion.
- Conditions
- Sarcoma, Soft Tissue Sarcoma (STS), Advanced Soft Tissue Sarcoma, Undifferentiated Pleomorphic Sarcoma (UPS), Dedifferentiated Liposarcoma (DDLPS)
- Being tested
- Lifileucel
- Keywords
- TIL, Tumor Infiltrating Lymphocytes, Cell Therapy, Cellular Immuno-therapy, IL2, Lifileucel, Sarcoma, Soft Tissue Sarcoma, Advanced Soft Tissue Sarcoma, LN-145, Non-myeloablative lymphodepletion (NMALD), SARATOGA, Undifferentiated pleomorphic sarcoma (UPS), Dedifferentiated liposarcoma (DDLPS)
- Medical subject headings
- Sarcoma, Histiocytoma, Malignant Fibrous, Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifileucelBiological
Also called LN-145
Study 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).
| Study group | Role | What they receive |
|---|---|---|
| Lifileucel | Experimental | Not described Receives: Biological: Lifileucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the IRC
Measured: 5 years
Secondary outcomes (11)
Complete Response Rate
To evaluate the efficacy of lifileucel as measured by CR rate per RECIST v1.1 as assessed by the IRC
Measured: 5 years
Duration of Response
To evaluate the efficacy of lifileucel as measured by DOR per RECIST v1.1 as assessed by the IRC
Measured: 5 years
Disease Control Rate
To evaluate the efficacy of lifileucel as measured by DCR per RECIST v1.1 as assessed by the IRC
Measured: 5 years
Progression-Free Survival
To evaluate the efficacy of lifileucel as measured by PFS per RECIST v1.1 as assessed by the IRC
Measured: 5 years
Objective Response Rate
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the investigators
Measured: 5 years
Complete Response Rate
To evaluate the efficacy of lifileucel as measured CR rate per RECIST v1.1 as assessed by the investigators
Measured: 5 years
Duration of Response
To evaluate the efficacy of lifileucel as measured by DOR per RECIST v1.1 as assessed by the investigators
Measured: 5 years
Disease Control Rate
To evaluate the efficacy of lifileucel as measured by DCR per RECIST v1.1 as assessed by the investigators
Measured: 5 years
Progression-Free Survival
To evaluate the efficacy of lifileucel as measured by PFS per RECIST v1.1 as assessed by the investigators
Measured: 5 years
Overall Survival
To evaluate the efficacy of lifileucel as measured by OS
Measured: 5 years
Adverse Events
To evaluate safety and tolerability of lifileucel
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start2 Oct 2026
- Primary completion1 Sep 2033 (estimated)
- Study completion1 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iovance Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741877
- Sponsor's protocol ID
- IOV-SAR-201
- Acronym
- 'SARATOGA'
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No