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CAR T-cell Therapy
Cell Therapy for Sarcoma
Phase 2
Waitlist Available
Research Sponsored by Adaptimmune
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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28])
Disease Control Rate (DCR)
Duration of Response (DOR)
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860
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Who is running the clinical trial?
AdaptimmuneLead Sponsor
20 Previous Clinical Trials
10,869 Total Patients Enrolled
GlaxoSmithKlineLead Sponsor
4,802 Previous Clinical Trials
8,377,995 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,701 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors
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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.
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