Study on Lifileucel (Tumor-infiltrating Lymphocytes) for Adults with Advanced Soft Tissue Sarcoma
Sponsor: Iovance Biotherapeutics, Inc.
ClinicalTrials ID:NCT07741877
This clinical trial is exploring the use of lifileucel, a treatment made from a patient's own immune cells, to see if it can help treat advanced soft tissue sarcoma in adults who have already received other treatments.
Patient Parameters
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Program Overview
The study aims to test the effectiveness and safety of lifileucel, a treatment made from a patient's own tumor-infiltrating lymphocytes, in adults with advanced soft tissue sarcoma. Participants will undergo surgery to remove tumor samples, which will be used to create the lifileucel treatment. The treatment process includes medications to prepare the body, the lifileucel infusion, and additional drugs to enhance the treatment's effectiveness. Participants will have regular follow-up visits for up to five years to monitor their health and the treatment's impact.
Description
In this study, researchers are investigating a new treatment called lifileucel for adults with advanced soft tissue sarcoma who have already tried other treatments. Lifileucel is made from a patient's own immune cells, which are collected from a tumor and then grown in a lab to help fight cancer.
Participants will first have surgery to remove a small piece of their tumor. This sample will be used to create the lifileucel treatment. Before receiving lifileucel, participants will take two medications (cyclophosphamide and fludarabine) for up to five days to prepare their body. Then, they will receive the lifileucel infusion, followed by up to four days of a drug called aldesleukin to boost the treatment's effectiveness.
After the treatment, participants will have regular check-ups every six weeks for the first six months, and then every three months for up to five years. These visits will help doctors monitor the participants' health and see how well the treatment is working.
Eligibility Criteria
Inclusion Criteria
- Must be 16 years or older to participate.
- Participants over 70 may join after a discussion with the study doctor.
- Must have a confirmed diagnosis of advanced soft tissue sarcoma that cannot be removed by surgery or has spread.
- Must have tried at least one, but no more than three, previous treatments, including one with anthracycline.
- The cancer must have worsened after the last treatment.
- Must have at least one tumor that can be removed for making lifileucel.
- After tumor removal, must have at least one measurable tumor left.
- Must be able to stop other cancer treatments before starting the study.
- Any planned surgeries must be done at least 14 days before tumor removal.
- Must have recovered from previous treatment side effects, except for certain conditions like hair loss.
- Must agree to use effective birth control if of childbearing potential.
- Must have good organ function.
- Must be willing to receive supportive care during the study.
Exclusion Criteria
- Cannot have untreated brain cancer that is causing symptoms.
- Cannot have a performance status of 2 or higher, need urgent treatment, or have a life expectancy of less than 6 months.
- Cannot have any active medical conditions that increase risks for the study.
- Cannot have a primary immune deficiency or AIDS.
- Cannot have allergies to any part of the study treatment.
- Cannot have had another cancer in the past 3 years, unless it was treated and is not likely to come back.
Other criteria may apply as defined by the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
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