Cell Therapy for Sarcoma
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, there are washout periods for prior radiotherapy and systemic chemotherapy, which means you may need to stop these treatments for a certain time before starting the trial.
What data supports the effectiveness of the treatment Lete-Cel for sarcoma?
Is cell therapy for sarcoma, like Lete-Cel, generally safe for humans?
Cell therapies like CAR-T cell treatments have been used safely in humans for other conditions, such as certain types of lymphoma. Common side effects include cytokine release syndrome (a strong immune reaction) and neurological issues, but these are usually manageable with proper medical care.678910
How is the treatment Lete-Cel unique for sarcoma?
Lete-Cel is a type of cell therapy that uses genetically modified T-cells to target specific proteins on sarcoma cells, which is different from traditional treatments that rely on chemotherapy or radiation. This approach is similar to CAR-T cell therapy, which has shown success in other cancers, and offers a novel way to treat sarcomas, especially those that are recurrent or metastatic.210111213
What is the purpose of this trial?
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.
Research Team
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Eligibility Criteria
This trial is for people over 10 years old with advanced synovial sarcoma or myxoid/round cell liposarcoma, which are types of tumors. Participants must have certain HLA-A2 genes and their tumor must express NY-ESO-1. They should be relatively healthy (good performance status) and not have had severe autoimmune diseases, previous specific cancer treatments, major surgery within the last month, or other serious health issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive human engineered T-cell therapies for advanced tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lete-Cel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adaptimmune
Lead Sponsor
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School