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CAR T-cell Therapy
Cell Therapy for Sarcoma
Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 54 months
Awards & highlights
Study Summary
This trial tests if a new type of cell therapy can safely and effectively treat advanced tumors. #cancerscience #celltherapy
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests Letetresgene autoleucel (lete-cel), a type of engineered T-cell therapy designed to target cancer cells in patients with specific genetic markers. It's part of a larger study on human-engineered T-cell therapies. Patients will also receive Cyclophosphamide and Fludarabine as part of the treatment process.See study design
What are the potential side effects?
Potential side effects may include immune system reactions due to the engineered T-cells attacking normal cells by mistake, infusion-related reactions from receiving the cells into your bloodstream, fatigue from treatment stress on your body, and possible complications related to organ function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 54 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 54 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28])
Disease Control Rate (DCR)
Duration of Response (DOR)
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Letetresgene autoleucelExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,465 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,923 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain.I have a cancer that is not fully in remission.I have a serious illness affecting my whole body.I have had or currently have a disease that damages the protective covering of my nerves.I have been treated with NY-ESO-1-specific T cells before.I have a severe autoimmune disease treated with steroids or immunosuppressants.My genetic test shows I have HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06.I have received a NY-ESO-1 vaccine or antibody treatment.I have had gene therapy with an integrating vector before.I have completed the required waiting period after my last cancer treatment.My tumor is positive for NY-ESO-1.I am mostly active and can carry out daily activities with little to no help.I have been diagnosed with synovial sarcoma or myxoid/round cell liposarcoma.I had major surgery within the last 28 days.I am at least 10 years old.My organs are functioning well and my blood cell counts are within the normal range.I have had a stem cell transplant from a donor.
Research Study Groups:
This trial has the following groups:- Group 1: Letetresgene autoleucel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Letetresgene autoleucel a secure treatment option for individuals?
"Our team at Power rates letetresgene autoleucel's safety as a 2, due to the existence of Phase 2 trial data that suggests security but no clinical evidence confirming its efficacy."
Answered by AI
Is it still possible to enroll in this research trial?
"As stated on clinicaltrials.gov, this therapeutic trial is now closed to new participants; the initial posting date was December 31st 2019 and the final edit was made on August 7th 2023. Despite its closure, there are still 2526 other medical trials currently recruiting patients at this time."
Answered by AI
How many medical centers are conducting this research within the city limits?
"Currently, the trial is running at 6 different medical establishments with locations in Dallas, Milwaukee and Montreal among others. To reduce travelling constraints, it can be advantageous to pick a site near your residence if you are interested in taking part."
Answered by AI
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