Lete-Cel for Synovial Sarcoma

Not currently recruiting at 41 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Lete-Cel for individuals with advanced synovial sarcoma or myxoid/round cell liposarcoma, cancers that have spread or cannot be surgically removed. The trial aims to assess the safety and effectiveness of this T-cell therapy in treating these challenging cancers. It may suit those who have not succeeded with standard treatments and have a specific genetic marker (HLA type) associated with their cancer. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing an opportunity to benefit from a potentially effective therapy.

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.

Is there any evidence suggesting that Lete-Cel is likely to be safe for humans?

Research has shown that letetresgene autoleucel, or lete-cel, generally has a manageable safety profile. In one study, 147 patients with sarcoma received lete-cel, and the treatment was well-tolerated. Another study found that lete-cel caused side effects that doctors could manage, even in patients with difficult-to-treat cancers like multiple myeloma. While lete-cel has shown promise in treating certain tumors, participants should discuss potential risks and side effects with their doctors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Letetresgene autoleucel (Lete-Cel) because it offers a novel approach to treating synovial sarcoma by harnessing the power of the body's immune system. Unlike traditional treatments like surgery, radiation, and chemotherapy, Lete-Cel is a type of immunotherapy that involves genetically modifying a patient's own T-cells to better recognize and attack cancer cells. This personalized approach not only targets the cancer more precisely but also has the potential to reduce side effects compared to conventional methods. By directly engaging the immune system, Lete-Cel may provide a more effective and potentially longer-lasting response.

What evidence suggests that Lete-Cel might be an effective treatment for synovial sarcoma?

Research has shown that Lete-Cel, the investigational treatment under study in this trial, may help treat synovial sarcoma, a type of cancer. Studies found that Lete-Cel can lead to lasting improvements in patients with this disease. Specifically, patients whose cancer cells have a protein called NY-ESO-1 experienced a 42% overall response rate (ORR), meaning 42% of these patients had a significant decrease in tumor size. These results suggest that Lete-Cel could be a promising treatment option for people with synovial sarcoma. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Letetresgene autoleucel Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Adaptimmune

Lead Sponsor

Trials

25

Recruited

10,000+

Citations

1. jitc.bmj.com jitc.bmj.com/content/13/Suppl_2/A366

320 Integrated efficacy and safety analysis of letetresgene ... Data was pooled and outputs present combined data and subgroup analyses summarized by indication and overall. Results A total of 178 sarcoma ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2500

Lete-cel in patients with synovial sarcoma or myxoid/round ... Results: As of the March 2, 2023 IA, 98 pts were apheresed, 73 pts received lete-cel (safety) and 45 pts were evaluable for efficacy. Median age ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12084024/

Letetresgene Autoleucel in Advanced/Metastatic Myxoid ... We conducted a pilot study to evaluate efficacy and safety of lete-cel in patients with advanced or metastatic MRCLS that express NY-ESO-1.

4. onclive.com onclive.com/view/lete-cel-generates-durable-responses-in-synovial-sarcoma-and-myoxid-round-cell-liposarcoma

Lete-Cel Generates Durable Responses in Synovial ... Patients with metastatic myxoid/round cell liposarcoma or synovial sarcoma expressing NY-ESO-1 and HLA achieved an ORR of 42% with lete-cel.

5. mskcc.org mskcc.org/clinical-updates/adoptive-cell-therapy-improves-outcomes-for-select-patients-with-advanced-synovial-sarcoma

Adoptive Cell Therapy Improves Outcomes for Select ... The adoptive cell therapy afamitresgene autoleucel (afami-cel) demonstrated a favorable response and duration of response in select patients with metastatic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10111356/

Safety and efficacy of letetresgene autoleucel alone or with ... Lete-cel had a manageable safety profile and demonstrated clear but transient antitumor activity in patients with relapsed/refractory multiple myeloma.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05993299

Study to Evaluate Safety and Antitumor Activity of Lete-Cel ... 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 ...