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CAR T-cell Therapy

Engineered T-Cell Therapy for Advanced Cancer (IGNYTE-ESO Trial)

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
Participant's tumor is positive for NY-ESO-1 expression by a designated central laboratory
Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

IGNYTE-ESO Trial Summary

This trial will see if human-engineered T-cell therapies are safe and effective in people with advanced tumors.

Who is the study for?
This trial is for people with advanced tumors that test positive for NY-ESO-1. Participants must be at least 10 years old, have a specific performance status, and match certain HLA types. They should have good organ function and measurable disease but no history of severe autoimmune diseases, previous similar treatments, or recent major surgery.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of genetically engineered T-cell therapy (lete-cel) combined with Fludarabine and Cyclophosphamide in treating solid tumors expressing NY-ESO-1 or LAGE-1a. It's designed to see how well these therapies work against advanced cancers.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related responses, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea from chemotherapy drugs like Fludarabine and Cyclophosphamide.

IGNYTE-ESO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is positive for NY-ESO-1.
Select...
I have been diagnosed with synovial sarcoma or myxoid/round cell liposarcoma.
Select...
I am at least 10 years old.
Select...
I have specific genetic markers (HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06).

IGNYTE-ESO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Substudy 1: Overall response rate (ORR)
Substudy 2: Overall response rate (ORR) as assessed by central independent review
Secondary outcome measures
Substudy 1 and 2: Area under the concentration/persistence time curve from zero to time t (AUC[0-t]) of letetresgene autoleucel
Substudy 1 and 2: Disease control rate (DCR)
Substudy 1 and 2: Duration of response (DOR)
+11 more

IGNYTE-ESO Trial Design

2Treatment groups
Experimental Treatment
Group I: Substudy 2: lete-cel in advanced (metastatic or unresectable) SS or MRCLS post anthracycline chemoExperimental Treatment3 Interventions
Eligible participants will be leukapheresed to manufacture engineered T cells. Participants will then receive letetresgene autoleucel.
Group II: Substudy 1: lete-cel in previously untreated advanced (metastatic or unresectable) SS or MRCLSExperimental Treatment3 Interventions
Eligible participants will be leukapheresed to manufacture engineered T cells. Participants will then receive letetresgene autoleucel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,067,349 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,827 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors

Media Library

Letetresgene autoleucel (lete-cel, GSK3377794) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03967223 — Phase 2
Tumors Research Study Groups: Substudy 1: lete-cel in previously untreated advanced (metastatic or unresectable) SS or MRCLS, Substudy 2: lete-cel in advanced (metastatic or unresectable) SS or MRCLS post anthracycline chemo
Tumors Clinical Trial 2023: Letetresgene autoleucel (lete-cel, GSK3377794) Highlights & Side Effects. Trial Name: NCT03967223 — Phase 2
Letetresgene autoleucel (lete-cel, GSK3377794) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03967223 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA okayed Letetresgene autoleucel (lete-cel, GSK3377794) for public use?

"Letetresgene autoleucel (lete-cel, GSK3377794) is still in Phase 2 clinical trials. This means that while there is some evidence supporting its safety, none yet exists to show that it is an effective treatment option."

Answered by AI

What is the primary purpose of Letetresgene autoleucel (lete-cel, GSK3377794)?

"Letetresgene autoleucel (lete-cel, GSK3377794) is the standard medication used to treat multiple sclerosis. However, this same drug can also be effective in treating other forms of cancer such as mixed-cell type lymphoma and leukemia."

Answered by AI

Are there any unfilled appointments in this clinical trial?

"The clinicaltrials.gov website indicates that this research is not looking for any more participants at the moment. The listing was created on December 31st, 2019 and last updated on October 28th, 2020. There are currently 3389 other trials actively recruiting patients."

Answered by AI

What are the desired outcomes of this research?

"The primary objective of this long-term study is to assess the ORR in Substudy 1. Additionally, researchers will be evaluating IO rates (defined as gene modified cell growth in PBMC samples) in both Substudy 1 and 2, OS rates in just Substudy 2, and finally the presence of ADA antibodies (with titers against letetresgene autoleucel) in all participants' serum samples."

Answered by AI

Are there any other similar studies to Letetresgene autoleucel (lete-cel, GSK3377794)?

"The first study involving letetresgene autoleucel (lete-cel, GSK3377794) was completed in 1997. City of Hope Comprehensive Cancer Center hosted the trial. There are presently 1274 completed studies and 928 active trials worldwide. A large number of these ongoing studies are situated in Chicago, Illinois."

Answered by AI

How many different hospitals or research facilities are participating in this study?

"This ongoing trial has already begun at 24 different locations, with more planned in the future. There are sites in major metropolitan areas such as Chicago, Minneapolis and Toronto. If enrolled, it would be ideal to attend the closest site to minimize travel time and expenses."

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Tried ifosfamide doxyrubicin and pazopanib . Dint work.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors
2019. "Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03967223.
All > Cancer > Oncology
~20 spots leftby Apr 2025
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