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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 weeks
Treatment ~ Varies
Follow Up ~up to approximately 54 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 54 months for reporting.

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 more

Awards & 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

Find a Location

Who is running the clinical trial?

AdaptimmuneLead Sponsor
22 Previous Clinical Trials
10,881 Total Patients Enrolled
GlaxoSmithKlineLead Sponsor
4,808 Previous Clinical Trials
8,381,371 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,711 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors

Media Library

Lete-Cel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05993299 — Phase 2
Tumors Research Study Groups: Letetresgene autoleucel
Tumors Clinical Trial 2023: Lete-Cel Highlights & Side Effects. Trial Name: NCT05993299 — Phase 2
Lete-Cel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05993299 — Phase 2
~1 spots leftby Dec 2025
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