SARATOGA

SARATOGA: A Study of Lifileucel in Advanced Soft Tissue Sarcoma

Agent: Lifileucel (LN-145)
Phase II
Status Recruiting
Sponsor Iovance Biotherapeutics, Inc.

 

For further information please also consult https://clinicaltrials.gov/study/NCT07741877.

SARATOGA is a Phase 2 study investigating lifileucel (LN-145), a treatment using immune cells collected from a patient’s own tumor, in previously treated advanced soft tissue sarcoma.

Tumor-infiltrating lymphocytes (TILs) are immune cells found inside tumors. Researchers grow these cells in a laboratory and infuse them back into the patient. The treatment also includes preparatory chemotherapy and a short course of interleukin-2.

WHO is the trial for?
  • People aged 16–70 (older patients may be considered after review)
  • Patients with unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS).
  • 1–3 previous systemic treatments, including an anthracycline-based treatment, and their cancer must have progressed.
  • At least one resectable tumor lesion. This is required for the collection of immune cells.
  • Good overall health status (ECOG 0-1)

Important exclusions include untreated brain metastases causing symptoms, certain immune deficiencies and serious active illnesses. The study team checks all eligibility criteria.

WHAT is the key question that this trial is attempting to answer?

 SARATOGA is evaluating whether a therapy with tumor-infiltrating lymphocytes is safe and effective for patients with advanced undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) with disease progression following prior systemic therapy.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is currently conducted in the US.

For further information check here.

Study contact:
Iovance Biotherapeutics Study Team
Phone +1 844-845-4682
Email: Clinical.Inquiries@iovance.com

STUDY DESIGN: What does the study look like?

 Open-label Phase 2 study, with approximately 80 participants planned.

  • Participants have a tumor sample surgically removed so immune cells can be collected and expanded in a laboratory.
  • They then receive preparatory chemotherapy (cyclophosphamide and fludarabine), one infusion of lifileucel, and a shortened course of interleukin-2 (aldesleukin).
  • There is no placebo group.

Researchers monitor tumor response and side effects.

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken