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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.

Iovance Biotherapeutics Study Team contact

844-845-4682

Clinical.Inquiries@iovance.com

United States2 sites, 2 recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

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.

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 groups in NCT07741877
Study groupRoleWhat they receive
LifileucelExperimentalNot described
Receives: Biological: Lifileucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Overall Survival

    To evaluate the efficacy of lifileucel as measured by OS

    Measured: 5 years

  11. 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.

  1. First posted3 Aug 2026
  2. Study start2 Oct 2026
  3. Primary completion1 Sep 2033 (estimated)
  4. Study completion1 Sep 2034 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Iovance Biotherapeutics Study Team (844-845-4682, Clinical.Inquiries@iovance.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07741877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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