Clinical trials: NY-ESO-1 Positive
Advanced Solid Tumors
NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes…
- Trial name
- NCT05881525
- Testing
- TC-N201 cells, IL-2, Fludarabine
- Where
- China
- Volunteers
- 18 people
- Sponsor
- TCRCure Biopharma Ltd.
Soft Tissue Sarcoma
Phase II Study of TAEST16001 in Soft Tissue Sarcoma
The main purpose of this trial is to evaluate the efficacy and safety of TAEST16001 cells in the treatment of advanced soft tissue sarcoma patients with HLA-A*02:01 tissue genotype and positive tumor antigen NY-ESO-1 expression.
- Trial name
- NCT05549921
- Testing
- NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)
- Where
- 2 sites in China
- Volunteers
- 8 people
- Sponsor
- Sun Yat-sen University
Sarcoma, Lung Cancers
An Open-label, Phase I Clinical Trial of Super1 TCR-T in NY-ESO-1-positive Patients With Advanced Solid Tumors
This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
- Conditions
- Sarcoma, Lung Cancers, Melanoma
- Trial name
- NCT06942143
- Testing
- Super1 TCR-T
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
Neoplasms
Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors
This trial will evaluate the safety and efficacy of first time in human engineered T-cell therapies, in participants with advanced tumors.
- Trial name
- NCT04526509
- Testing
- GSK3901961, GSK3845097, GSK4427296
- Where
- 17 sites in United States, Australia and 4 more
- Volunteers
- 12 people
- Sponsor
- Adaptimmune
Neoplasms
Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab
This trial will evaluate safety and tolerability of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with non-small cell lung cancer.
- Trial name
- NCT03709706
- Testing
- Lete-cel, Pembrolizumab
- Where
- 31 sites in United States, Canada and 3 more
- Volunteers
- 34 people
- Sponsor
- GlaxoSmithKline
Neoplasms
Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma
This trial will evaluate safety, tolerability, and efficacy of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with relapsed and refractory multiple myeloma.
- Trial name
- NCT03168438
- Testing
- Letetresgene autoleucel, Letetresgene autoleucel with pembrolizumab, Fludarabine
- Where
- 5 sites in United States
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Neoplasms
Letetresgene Autoleucel Engineered T Cells in NY-ESO -1 Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
This trial will evaluate safety and efficacy of letetresgene autoleucel (GSK3377794) in participants with metastatic NSCLC.
- Trial name
- NCT02588612
- Testing
- letetresgene autoleucel (GSK3377794), Cyclophosphamide, Fludarabine
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- GlaxoSmithKline
Neoplasms
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
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.
- Trial name
- NCT06703346
- Testing
- Letetresgene autoleucel (Lete-Cel (GSK3377794)), Cyclophosphamide, Fludarabine
- Where
- 38 sites in United States, Canada and 5 more
- Volunteers
- 82 people
- Sponsor
- USWM CT, LLC
Neoplasms
Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
To assess the safety, tolerability and determine recommended phase 2 dose (RP2D) of GSK3845097 in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive participants with New York esophageal squamous cell carcinoma (NY-ESO)-1…
- Trial name
- NCT05943990
- Testing
- GSK3845097, Cyclophosphamide, Fludarabine
- Where
- 21 sites in United States, Australia and 4 more
- Volunteers
- 5 people
- Sponsor
- Adaptimmune
Select Advanced Solid Tumors
Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers
IMCnyeso is a bispecific fusion protein designed for the treatment of cancers that express NY-ESO-1 and/or LAGE-1A. This was a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in HLA-A*02:01-positive…
- Trial name
- NCT03515551
- Testing
- IMCnyeso
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 29 people
- Sponsor
- Immunocore Ltd
Neoplasms
Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors.
- Trial name
- IGNYTE-ESO (NCT03967223)
- Testing
- Letetresgene autoleucel (lete-cel, GSK3377794), Fludarabine, Cyclophosphamide
- Where
- 38 sites in United States, Canada and 5 more
- Volunteers
- 103 people
- Sponsor
- USWM CT, LLC
Neoplasms
Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma
This trial will evaluate safety and efficacy of Letetresgene autoleucel (GSK3377794) in participants with advanced myxoid/round cell liposarcoma or high-grade myxoid liposarcoma.
- Trial name
- NCT02992743
- Testing
- letetresgene autoleucel (GSK3377794), Cyclophosphamide, Fludarabine
- Where
- 6 sites in United States
- Volunteers
- 23 people
- Sponsor
- GlaxoSmithKline
Soft Tissue Sarcoma
TAEST16001 in the Treatment of Soft Tissue Sarcoma
This study is an open, single arm, dose increasing early clinical study, which is divided into two parts: "3 + 3" designed dose escalation study and extended group study.
- Trial name
- NCT04318964
- Testing
- TAEST16001 cells
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Sun Yat-sen University
HLA-A*0201 Positive Cells Present, Locally Advanced Malignant Neoplasm
Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer
This phase I clinical trial evaluates the safety and feasibility of administering NY-ESO-1 TCR (T cell receptor)engineered peripheral blood mononuclear cells (PBMC) and peripheral blood stem cells (PBSC) after a myeloablative…
- Conditions
- HLA-A*0201 Positive Cells Present, Locally Advanced Malignant Neoplasm, NY-ESO-1 Positive, Unresectable Malignant Neoplasm
- Trial name
- NYESO SCT (NCT03240861)
- Testing
- 18F-FHBG, Aldesleukin, Busulfan
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Jonsson Comprehensive Cancer Center
HLA-A2 Positive Cells Present, Metastatic Malignant Neoplasm
Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes
This pilot clinical trial studies the side effects of anti-ESO (cancer/test antigen) murine T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination chemotherapy with cyclophosphamide and…
- Conditions
- HLA-A2 Positive Cells Present, Metastatic Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain
- Trial name
- NCT02774291
- Testing
- Aldesleukin, Anti-thyroglobulin mTCR-transduced Autologous Peripheral Blood Lymphocytes, Cyclophosphamide
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Albert Einstein College of Medicine
Triple Negative Breast Cancer
A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer
This phase Ib trial tests the safety, side effects and best dose of anti-HLA-A2/NY-ESO-1 T-cell receptor (TCR)-transduced autologous T lymphocytes (A2-ESO-1 TCR-T cells) in treating patients with NY-ESO-1 overexpression positive…
- Trial name
- NCT05989828
- Testing
- Aldesleukin, Anti-HLA-A2/NY-ESO-1 TCR-transduced Autologous T Lymphocytes, Biopsy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Southern California
HLA-A*0201 Positive Cells Present, NY-ESO-1 Positive Tumor Cells Present
TCR Genetically Engineered PBMC and PBSC After Melphalan Conditioning Regimen in Treating Participants With Relapsed and Refractory Multiple Myeloma
This phase I trial studies the side effects of NY-ESO-1 TCR engineered peripheral blood mononuclear cells (PBMC) and peripheral blood stem cells (PBSC) after melphalan conditioning regimen in treating participants with multiple…
- Conditions
- HLA-A*0201 Positive Cells Present, NY-ESO-1 Positive Tumor Cells Present, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Trial name
- NYSCT MM (NCT03506802)
- Testing
- 18F-FHBG, Aldesleukin, Cellular Therapy
- Where
- United States
- Sponsor
- Jonsson Comprehensive Cancer Center
Neoplasms
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
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.
- Trial name
- NCT05993299
- Testing
- Letetresgene autoleucel, Cyclophosphamide, Fludarabine
- Where
- 38 sites in United States, Canada and 5 more
- Volunteers
- 7 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Solid Tumors
TCR-T Cells for the Treatment NY-ESO-1-positive Advanced Solid Tumors
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a Cancer-Testis Antigen (CTA) which is expressed in various tumors. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell…
- Trial name
- NCT05648994
- Testing
- TCR-T cells, Fludarabine, Cyclophosphamide Capsules
- Volunteers
- 30 people
- Sponsor
- Fujian Cancer Hospital
HLA-A*0201 Positive Cells Present, NY-ESO-1 Positive Tumor Cells Present
Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma
This phase I trial studies how well autologous NY-ESO-1-specific CD8-positive T lymphocytes (modified T lymphocytes [T cells]), chemotherapy, and aldesleukin with or without dendritic cell-targeting lentiviral vector ID-LV305…
- Conditions
- HLA-A*0201 Positive Cells Present, NY-ESO-1 Positive Tumor Cells Present, Recurrent Myxoid Liposarcoma, Recurrent Synovial Sarcoma
- Trial name
- NCT03450122
- Testing
- Aldesleukin, Autologous NY-ESO-1-specific CD8-positive T Lymphocytes, Cyclophosphamide
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- M.D. Anderson Cancer Center