Clinical trial locations
- France
- Germany
- Italy
- Netherlands
- Poland
- Spain
Long-Term Follow-Up Study for Patients with Myxoid/Round Cell Liposarcoma, Multiple Myeloma, Non-Small Cell Lung Cancer, or Synovial Sarcoma Treated with Letetresgene Autoleucel
This study focuses on the long-term safety monitoring of patients who have already received an innovative cell therapy called letetresgene autoleucel. The treatment involves genetically modified immune cells designed to help the body fight cancer more effectively.
Who can join: Patients who have already received at least one infusion of letetresgene autoleucel through a previous study or managed access program are eligible. Participants must be able to provide informed consent and understand the study requirements. Both men and women can participate, though they must agree to use contraception for at least 12 months after treatment or until the modified cells are no longer detectable in their blood, whichever is longer.
Who cannot join: The exclusion criteria are primarily focused on patients who have not received the specific cell therapy being studied.
Study focus: The main goal is to monitor participants over the long term for any delayed side effects that might occur after receiving the genetically modified cell therapy. These could include new cancers, neurological problems, autoimmune disorders, blood disorders, or infections. Blood samples will be collected regularly to check for specific markers and to track how long the modified cells remain in the body. The study will continue until 2032, providing valuable information about the safety of this innovative treatment approach.
Treatment: The study involves the adoptive cell therapy known as GSK3377794 or letetresgene autoleucel, which contains genetically modified T cells that have been engineered to target cancer cells more effectively.
Study of Letetresgene Autoleucel for Patients with Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
This trial investigates a personalized cell therapy approach for patients with advanced disease. The treatment involves collecting a patient's own immune cells, modifying them in the laboratory, and then infusing them back into the patient to fight cancer.
Who can join: Participants must be at least 10 years old and have a confirmed diagnosis of myxoid/round cell liposarcoma that has spread or cannot be surgically removed. The cancer must show specific genetic changes involving chromosomes 12, 16, and 22. Patients must have already received at least one standard treatment including drugs like doxorubicin. The tumor must test positive for a protein called NY-ESO-1 in at least 30% of cells, and patients must have specific genetic markers called HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06. Adequate heart, liver, kidney, and blood cell function is required, and patients must have a life expectancy of at least 24 weeks.
Who cannot join: Patients whose tumors do not express the NY-ESO-1 protein or who lack the required HLA genetic markers cannot participate.
Study focus: The trial aims to evaluate how effective and safe the genetically modified T cell therapy is for treating these specific types of cancer. The treatment process begins with leukapheresis, a procedure to collect white blood cells. These cells are then genetically engineered to recognize and attack cancer cells expressing the NY-ESO-1 protein. After modification, the cells are infused back into the patient's bloodstream. Researchers will monitor how the cancer responds to treatment and track any side effects. Some participants may also receive other anti-cancer medications alongside the cell therapy.
Treatment: The investigational drug is GSK3377794, consisting of NY-ESO-1-specific T cells that have been genetically modified to target cancer cells. Some patients may also receive additional anti-cancer agents to enhance the effectiveness of the treatment.
Study of Afamitresgene Autoleucel for Patients with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
This trial investigates a personalized immunotherapy approach using genetically modified T cells to treat advanced forms of these rare cancers.
Who can join: Patients aged 16 to 75 with confirmed advanced myxoid liposarcoma that has spread or cannot be surgically removed are eligible. Participants must have previously received treatment containing anthracycline or ifosfamide, or at least one other treatment if they cannot tolerate these drugs. The cancer must be measurable according to specific criteria, and patients must test positive for HLA-A*02 genetic markers. The tumor must show expression of a protein called MAGE-A4 in at least 30% of cells. Good heart function (left ventricular ejection fraction of 50% or higher) is required, and patients must be suitable for a blood cell collection procedure called leukapheresis. Adequate organ function confirmed through laboratory tests is necessary. Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control for at least 12 months or 4 months after the modified cells are no longer detectable, whichever is longer. Men must be surgically sterile or agree to use contraception and abstain from sex with women who can become pregnant for 4 months after treatment.
Who cannot join: Patients who are not HLA-A*02 positive or whose cancer does not express MAGE-A4 cannot participate.
Study focus: The trial evaluates the effectiveness of afamitresgene autoleucel, a therapy using genetically modified T cells. The process begins with leukapheresis to collect white blood cells, which are then sent to a laboratory for genetic modification. These modified cells, called ADP-A2M4 SPEAR T cells, are designed to recognize and attack cancer cells expressing the MAGE-A4 protein. Before receiving the modified cells, patients undergo a short course of chemotherapy called lymphodepletion to reduce existing immune cells and help the modified T cells work more effectively. The genetically modified cells are then infused back into the patient through an intravenous route. Participants are closely monitored for side effects and treatment effectiveness through regular follow-up visits and health assessments.
Treatment: Afamitresgene autoleucel consists of ADP-A2M4 SPEAR T cells, which are the patient's own T cells genetically modified to target cancer cells expressing the MAGE-A4 protein. The treatment also involves lymphodepletion chemotherapy given before the cell infusion.
Summary
The five ongoing clinical trials for myxoid liposarcoma reflect a strong focus on innovative immunotherapy approaches, with three trials testing genetically modified T cell therapies. These personalized treatments involve collecting a patient's own immune cells, modifying them to better recognize cancer cells, and infusing them back into the patient. Spain and Italy are the most active countries in terms of trial availability, with four and three trials respectively, while France and the Netherlands each host multiple studies. Germany and Poland have fewer but still important ongoing research efforts.
Most trials specifically target patients with advanced or metastatic disease who have already received at least one previous treatment. A common requirement across several studies is the presence of specific genetic markers (such as HLA-A*02 alleles) and protein expressions (like NY-ESO-1 or MAGE-A4), highlighting the personalized nature of these treatments. The trials also explore combination approaches, such as adding tTF-NGR to standard chemotherapy or injecting drugs directly into tumors, representing diverse strategies to improve outcomes for this challenging cancer.
The studies emphasize long-term monitoring, with one follow-up trial extending until 2032, reflecting the importance of understanding the lasting effects of these new therapies. Patients interested in participating should discuss eligibility requirements with their oncology team, as most trials require specific genetic and molecular characteristics of the tumor.