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CAR T-cell Therapy

Lete-Cel for Synovial 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
Participant has confirmed evidence of a relevant disease-specific translocation per study criteria
Left ventricular ejection fraction ≥45% with no evidence of clinically significant pericardial effusion
Must not have
Any other prior malignancy that is not in complete remission
Central nervous system (CNS) metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years post-t-cell infusion
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if using engineered T-cells is safe and effective in treating advanced tumors. It is a part of a larger study called the Master study NCT03967223.

Who is the study for?
This trial is for people with advanced synovial sarcoma or myxoid/round cell liposarcoma that have already been treated. Participants must have a specific immune system marker called HLA-A2 and their tumors need to test positive for NY-ESO-1.
What is being tested?
The study is testing Letetresgene autoleucel, an experimental T-cell therapy designed to target cancer cells in patients with certain advanced tumors. It's part of a larger research project on engineered T-cell therapies.
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response, such as flu-like symptoms, fatigue, fever, and possible risks associated with genetically modified T-cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disease has a specific genetic change according to the study's requirements.
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My heart pumps well and I don't have fluid around it.
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I have received or am receiving a standard cancer treatment that includes anthracyclines.
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I tested positive for specific immune system markers.
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My tumor tested positive for NY-ESO-1.
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I am at least 10 years old.
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I weigh at least 40 kg.
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I have been diagnosed with synovial sarcoma or myxoid/round cell liposarcoma.
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My cancer has spread and cannot be surgically removed without major loss of function.
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My cancer has worsened after previous treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have another cancer that is not fully in remission.
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My cancer has spread to my brain or spinal cord.
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I have received a NY-ESO-1 vaccine or antibody treatment.
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I have had gene therapy with an integrating vector before.
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I have had a stem cell transplant from a donor.
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I've had high-dose radiation to my pelvis, spine, or long bones.
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I have been treated with NY-ESO-1-specific T cells before.
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I do not have any major illnesses or nerve diseases.
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I have had chemotherapy within the last 3 weeks before starting treatment to reduce my white blood cells.
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I had a cancer vaccine 2 months ago without improvement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years post-t-cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years post-t-cell infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ORR (Overall Response Rate)
Secondary study objectives
Area Under the Time Curve from Zero to Time 28 Days (AUC [0-28])
DCR (Disease Control Rate)
DOR (Duration of response)
+11 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 Treatment1 Intervention

Find a Location

Who is running the clinical trial?

AdaptimmuneLead Sponsor
24 Previous Clinical Trials
10,900 Total Patients Enrolled
~15 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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