Lete-Cel for Synovial Sarcoma

Recruiting at 37 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Adaptimmune

Must be taking: Anthracyclines, Ifosfamide

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: CNS metastases, Prior gene therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

87 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received cytotoxic therapy within 3 weeks or systemic corticosteroids within 2 weeks before starting the trial's lymphodepleting chemotherapy.

Eligibility Criteria

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.

Inclusion Criteria

My disease has a specific genetic change according to the study's requirements.

I am healthy enough for a procedure to collect white blood cells and have good veins for it.

My heart pumps well and I don't have fluid around it.

Exclusion Criteria

I have another cancer that is not fully in remission.

My cancer has spread to my brain or spinal cord.

I have received a NY-ESO-1 vaccine or antibody treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive T-cell infusion and are monitored for safety and efficacy

4 weeks

Multiple visits for infusion and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 54 months

Long-term Follow-up

Participants are monitored for overall survival and long-term safety

Up to 15 years post-T-cell infusion

Treatment Details

Interventions

• Lete-Cel

Trial Overview 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.

Participant Groups

Group I: Letetresgene autoleucel Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Adaptimmune

Lead Sponsor

Trials

25

Recruited

10,000+