7 Participants Needed

Cell Therapy for Sarcoma

Recruiting at 43 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, there are washout periods for prior radiotherapy and systemic chemotherapy, which means you may need to stop these treatments for a certain time before starting the trial.

What data supports the effectiveness of the treatment Lete-Cel for sarcoma?

Lete-Cel, a type of cell therapy, has shown promise in treating metastatic synovial sarcoma with a 50% overall response rate in a study involving 45 patients. This suggests that Lete-Cel could be an effective treatment option for this type of sarcoma.12345

Is cell therapy for sarcoma, like Lete-Cel, generally safe for humans?

Cell therapies like CAR-T cell treatments have been used safely in humans for other conditions, such as certain types of lymphoma. Common side effects include cytokine release syndrome (a strong immune reaction) and neurological issues, but these are usually manageable with proper medical care.678910

How is the treatment Lete-Cel unique for sarcoma?

Lete-Cel is a type of cell therapy that uses genetically modified T-cells to target specific proteins on sarcoma cells, which is different from traditional treatments that rely on chemotherapy or radiation. This approach is similar to CAR-T cell therapy, which has shown success in other cancers, and offers a novel way to treat sarcomas, especially those that are recurrent or metastatic.210111213

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.

Research Team

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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.

Inclusion Criteria

My genetic test shows I have HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06.
My tumor is positive for NY-ESO-1.
I am mostly active and can carry out daily activities with little to no help.
See 5 more

Exclusion Criteria

Prior radiation exceeds protocol specified limits
My cancer has spread to my brain.
I have a cancer that is not fully in remission.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive human engineered T-cell therapies for advanced tumors

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 54 months

Treatment Details

Interventions

  • Lete-Cel
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Letetresgene autoleucelExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adaptimmune

Lead Sponsor

Trials
25
Recruited
10,000+

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
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Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

CAR T Cell therapy is a promising new treatment for sarcomas, which have seen stagnant survival rates, particularly in recurrent or metastatic cases, highlighting the urgent need for novel therapies.
Recent studies have identified several sarcoma-associated antigens suitable for CAR T Cell targeting, such as HER2 and GD2, showing encouraging results and suggesting that this therapy could improve outcomes for sarcoma patients.
Chimeric antigen receptor T (CAR-T) cell immunotherapy for sarcomas: From mechanisms to potential clinical applications.Thanindratarn, P., Dean, DC., Nelson, SD., et al.[2020]
In a study involving 190 sarcoma tumor specimens, researchers successfully isolated tumor-infiltrating lymphocytes (TILs) from 54 of 92 primary sarcoma samples, indicating that certain sarcoma subtypes can provide enough TILs for potential immunotherapy.
The optimized protocol for expanding TILs demonstrated that these cells retained their ability to react and release IFNγ upon stimulation, suggesting their viability for future personalized immunotherapy treatments in sarcoma patients.
Investigating the Potential of Isolating and Expanding Tumour-Infiltrating Lymphocytes from Adult Sarcoma.Ko, A., Coward, VS., Gokgoz, N., et al.[2022]
In a study involving 14 Japanese patients with relapsed or refractory aggressive large B-cell lymphoma, the CAR T-cell therapy lisocabtagene maraleucel (liso-cel) showed a 70% objective response rate and a 50% complete response rate, indicating significant efficacy.
The treatment had a manageable safety profile, with common side effects including neutropenia (90%) and cytokine release syndrome (50%), but no severe (grade ≥3) cytokine release syndrome events were reported.
Phase 2 results of lisocabtagene maraleucel in Japanese patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.Makita, S., Yamamoto, G., Maruyama, D., et al.[2023]

References

Biomarker correlates with response to NY-ESO-1 TCR T cells in patients with synovial sarcoma. [2022]
Chimeric antigen receptor T (CAR-T) cell immunotherapy for sarcomas: From mechanisms to potential clinical applications. [2020]
Investigating the Potential of Isolating and Expanding Tumour-Infiltrating Lymphocytes from Adult Sarcoma. [2022]
Innovative Breakthroughs for the Treatment of Advanced and Metastatic Synovial Sarcoma. [2023]
Patient-derived xenografts for individualized care in advanced sarcoma. [2022]
Phase 2 results of lisocabtagene maraleucel in Japanese patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. [2023]
Chimeric Antigen Receptor-T Cell Therapy: Practical Considerations for Implementation in Europe. [2020]
Real-world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B-cell lymphoma. [2021]
Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19+ hematologic indications. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Pushing forward in sarcoma with a new TCR targeting NY-ESO-1. [2023]
Ewing sarcoma dissemination and response to T-cell therapy in mice assessed by whole-body magnetic resonance imaging. [2021]
Adoptive cell therapy for sarcoma. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Donor lymphocyte infusions in adolescents and young adults for control of advanced pediatric sarcoma. [2022]
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