Ongoing Clinical Trials for Round Cell Liposarcoma
Four clinical trials are currently investigating new treatments for round cell liposarcoma, a rare form of cancer that develops in fat cells. These trials are testing innovative cell therapies and combination treatments across several European countries, offering hope for patients with advanced or metastatic disease who have not responded to standard treatments.
Clinical trial locations
- France
- Study of Afamitresgene Autoleucel for Patients with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
- Study of Letetresgene Autoleucel for Patients with Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
- Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas
- Germany
- Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas
- Study of Trabectedin alone versus Trabectedin with tTF-NGR combination therapy in adults with metastatic or refractory soft tissue sarcoma who failed first-line treatment
- Italy
- Netherlands
- Poland
- Spain
- Study of Afamitresgene Autoleucel for Patients with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
- Study of Letetresgene Autoleucel for Patients with Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
- Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas
Study of Letetresgene Autoleucel for Patients with Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
This trial is investigating a novel treatment approach called GSK3377794, also known as letetresgene autoleucel, which uses the patient’s own immune cells to fight cancer. The therapy involves collecting T cells from the patient, genetically modifying them in a laboratory to recognize and attack cancer cells expressing specific proteins called NY-ESO-1 and LAGE-1a, and then infusing them back into the patient’s body.
Main inclusion criteria: Patients must be at least 10 years old with a confirmed diagnosis of myxoid/round cell liposarcoma or synovial sarcoma that has spread or cannot be removed by surgery. The cancer must show specific genetic changes known as translocations and test positive for the NY-ESO-1 protein in at least 30% of tumor cells. Patients must have received or be currently receiving at least one standard treatment and must carry specific genetic markers called HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06. Adequate heart, organ, and blood cell function is required, along with a life expectancy of at least 24 weeks.
Main exclusion criteria: Patients without the specific tumor types being studied, those whose tumors do not express the NY-ESO-1 or LAGE-1a markers, and patients lacking the required HLA genetic markers cannot participate.
Focus and goal: The trial aims to evaluate the effectiveness and safety of genetically engineered T cell therapy as a treatment option for these rare cancers. Researchers will monitor how the cancer responds to treatment and track any side effects throughout the study period.
Investigational drugs: The main treatment is NY-ESO-1-Specific T cells (GSK3377794), which are genetically modified immune cells designed to target cancer cells. Some participants may also receive additional anti-cancer agents to enhance the effectiveness of the T cell therapy.
Study of Trabectedin alone versus Trabectedin with tTF-NGR combination therapy in adults with metastatic or refractory soft tissue sarcoma who failed first-line treatment
This study compares two treatment approaches for patients with soft tissue sarcomas that have spread or not responded to previous treatments. One group receives trabectedin alone, while the other receives trabectedin combined with an experimental drug called tTF-NGR. The combination therapy is designed to concentrate chemotherapy medication inside the tumor, potentially making treatment more effective.
Main inclusion criteria: Patients must be between 18 and 75 years old with confirmed high-grade soft tissue sarcoma, including various types of liposarcoma, that did not respond to previous anthracycline treatment or where anthracyclines cannot be used. The tumor must test positive for a protein marker called CD13 with a score of 1 or higher and have at least one measurable tumor that has not been treated with radiation. Patients must have a life expectancy of at least 3 months and be able to carry out daily activities. Both men and women must agree to use effective birth control during and after the study.
Main exclusion criteria: Patients outside the age range of 18-75, those without confirmed soft tissue sarcoma diagnosis, anyone with negative CD13 test results, pregnant or breastfeeding women, and those with severe heart, liver, or kidney problems cannot participate. Previous treatment with trabectedin also excludes patients from the study.
Focus and goal: The trial investigates whether adding tTF-NGR to standard trabectedin treatment helps control cancer for a longer period. Researchers will monitor tumor response through regular imaging tests and medical examinations.
Investigational drugs: Trabectedin is a chemotherapy medication that interferes with cancer cell growth. tTF-NGR is an experimental protein therapy that targets blood vessels in tumors to help trap the chemotherapy medication where it is needed most. Both medications are administered through intravenous infusion.
Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas
This trial examines a new treatment called INT230-6, which is injected directly into tumors. The study compares this approach with standard care treatments currently used in the United States for patients with liposarcoma, undifferentiated pleomorphic sarcoma, and leiomyosarcoma that has spread to other parts of the body.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of specific soft tissue sarcoma subtypes, including liposarcoma, that cannot be removed by surgery, is locally advanced, or has spread. Patients must have received at least one previous treatment for advanced disease and shown disease progression, but should not have had more than two previous treatments. At least one tumor must be measurable and suitable for direct injection, measuring at least 2 cm. Adequate organ function, confirmed through blood tests, is required. Women of childbearing potential must agree to use effective contraception during the study and for at least 7 months after, while men must use contraception for 6 months after the study ends.
Main exclusion criteria: Patients with cancer types not specified in the study, those who have had recent major surgery, people with severe heart problems or uncontrolled infections, and pregnant or breastfeeding women cannot participate. Patients with severe liver or kidney disease, a history of allergic reactions to study medications, or recent participation in another clinical trial are also excluded.
Focus and goal: The study aims to determine whether INT230-6 can improve overall survival compared to standard treatments. Researchers will closely monitor participants’ health, response to treatment, side effects, and quality of life throughout the study period, which is expected to last up to 24 months.
Investigational drugs: INT230-6 is a combination therapy containing vinblastine sulfate and cisplatin, two chemotherapy drugs, along with a proprietary formulation called SHAO. This treatment is injected directly into tumors. Standard care options may include Halaven (eribulin), Trabectedin, or Pazopanib, depending on the treatment group assigned.
Study of Afamitresgene Autoleucel for Patients with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
This clinical trial tests a cell therapy called afamitresgene autoleucel, which uses genetically modified T cells to fight cancer. The treatment involves collecting white blood cells from the patient through a process called leukapheresis, modifying them in a laboratory to create ADP-A2M4 SPEAR™ T cells that target cancer cells, and then infusing them back into the patient after a short course of chemotherapy to prepare the immune system.
Main inclusion criteria: Patients must be between 16 and 75 years old with a confirmed diagnosis of advanced synovial sarcoma or myxoid liposarcoma that has spread or cannot be safely removed by surgery. Previous treatment with anthracycline or ifosfamide is required, or at least one other treatment if these cannot be tolerated. The cancer must be measurable and test positive for specific genetic markers called HLA-A*02 alleles. At least 30% of tumor cells must show the presence of a protein called MAGE-A4. The heart’s pumping ability must be 50% or higher, and patients must be fully active or able to carry out light work. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control for at least 12 months or until modified cells are no longer detected in the blood. Men must also agree to use birth control for 4 months after treatment.
Main exclusion criteria: Patients without the specific cancer types being studied, those who are not HLA-A*02 positive, and patients whose cancer does not express the MAGE-A4 protein cannot participate. Age restrictions also apply, excluding those outside the specified range.
Focus and goal: The study evaluates how effective genetically modified T cells are in targeting and destroying cancer cells in patients with these rare sarcomas. Researchers will monitor tumor response, side effects, and overall health throughout the trial and during long-term follow-up.
Investigational drugs: ADP-A2M4 SPEAR™ T cells are genetically modified immune cells taken from the patient’s own body and altered to better recognize and attack cancer cells expressing the MAGE-A4 protein. Before receiving these cells, patients undergo lymphodepletion chemotherapy to reduce existing immune cells and help the modified T cells work more effectively.
Summary
These four clinical trials offer promising treatment options for patients with round cell liposarcoma and related soft tissue sarcomas across several European countries. Two of the trials focus on advanced cell therapy approaches using genetically modified T cells that target specific proteins on cancer cells, while the other two investigate combination chemotherapy treatments administered either directly into tumors or through standard infusion.
France, Spain, and Italy appear most frequently as trial locations, with France hosting three of the four studies. Germany and Poland also participate in select trials. The concentration of trials in these countries reflects established cancer research centers with expertise in treating rare sarcomas.
A notable feature across multiple trials is the requirement for specific genetic markers, either in the patient (such as HLA-A*02 variants) or in the tumor itself (such as NY-ESO-1, MAGE-A4, or CD13 expression). These personalized medicine approaches aim to identify patients most likely to benefit from targeted treatments.
All trials require patients to have received at least one previous treatment, focusing on those whose cancer has progressed despite standard therapy or who cannot tolerate conventional treatments. The studies typically expect to continue through 2025-2029, allowing researchers sufficient time to gather comprehensive data on treatment effectiveness and long-term safety.
