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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 Adaptimmune
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)
Must not have
Previous allogeneic hematopoietic stem cell transplant
History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease (e.g. Crohn's disease, systemic lupus) requiring steroids or other immunosuppressive treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.
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I have been diagnosed with synovial sarcoma or myxoid/round cell liposarcoma.
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I am at least 10 years old.
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I have specific genetic markers (HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a stem cell transplant from a donor.
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I have a severe autoimmune disease that needed strong medication in the last year.
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I have had gene therapy with an integrating vector before.
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My cancer has spread to my brain.
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I have a cancer that is not fully in remission.
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I have received a NY-ESO-1 vaccine or antibody treatment.
Select...
I have been treated with NY-ESO-1-specific T cells before.
Select...
I have had or currently have a disease that damages the protective covering of my nerves.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Substudy 1: Overall response rate (ORR)
Substudy 2: Overall response rate (ORR) as assessed by central independent review
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860

Find a Location

Who is running the clinical trial?

AdaptimmuneLead Sponsor
20 Previous Clinical Trials
10,773 Total Patients Enrolled
GlaxoSmithKlineLead Sponsor
4,802 Previous Clinical Trials
8,377,899 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,605 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
~18 spots leftby Nov 2025
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