Table 3 Clinical trials of engineered TCR-T cells for neoantigens (TCR-T trials registered in clinicalTrials.gov were summarized as of July 17th 2023.)
From: Neoantigen-targeted TCR-engineered T cell immunotherapy: current advances and challenges
NCT Number | Title | Target neoantigen | Cancers | Interventions | Phases/Status |
|---|---|---|---|---|---|
NCT05478837 | Genetically Modified Cells (KIND T Cells) for the Treatment of HLA-A*0201-Positive Patients With H3.3K27M-Mutated Glioma | H3.3K27M | Diffuse Midline Glioma, H3 K27M-Mutant | Biological: Autologous Anti-H3.3K27M TCR-expressing T-cells | Phase 1/Not yet recruiting |
Drug: Cyclophosphamide,Fludarabine | |||||
NCT05438667 | TCR-T Cell Therapy on Advanced Pancreatic Cancer and Other Solid Tumors | KRAS G12V and G12D | Pancreatic Cancer | Biological: TCR-T therapy | Early Phase 1Recruiting |
NCT05349890 | Personalized TCR-T: Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T) | one to five tumor-specific neoantigens expressed by their autologous tumor | Malignant Epithelial Neoplasms | Biological: TCR-transduced T cells | Phase 1/Enrolling by invitation |
Drug: CDX-1140, Pembrolizumab | |||||
NCT05194735 | Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors | unspecified | Gynecologic CancerColorectal Cancer|Pancreatic Cancer(and 9 more…) | Biological: Neoantigen specific TCR-T cell drug product, Aldesleukin (IL-2) | Phase 1|Phase 2/Recruiting |
NCT04520711 | Hotspot TCR-T: A Phase I/Ib Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T) | one to five tumor-specific neoantigens expressed by their autologous tumor | Malignant Epithelial Neoplasms | Biological: TCR-transduced T cells | Phase 1/Recruiting |
Drug: CDX-1140, Pembrolizumab | |||||
NCT04146298 | Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer | KRAS G12V | Pancreatic Cancer|Pancreatic Neoplasms|Pancreatic Ductal Adenocarcinoma|Advanced Cancer | Biological: Mutant KRAS G12V-specific TCR transduced autologous T cells | Phase 1|Phase 2/Recruiting |
Drug: Cyclophosphamide, Fludarabine, Anti-PD-1 monoclonal antibody | |||||
NCT03970382 | A Study of Gene Edited Autologous Neoantigen Targeted TCR-T Cells With or Without Anti-PD-1 in Patients With Solid Tumors | unspecified | Solid Tumor | Biological: NeoTCR-P1 adoptive cell therapy, nivolumab, IL-2 | Phase 1/Suspended |
NCT03745326 | Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients | KRAS G12D | Gastrointestinal Cancer|Pancreatic Cancer|Gastric Cancer(and 2 more…) | Biological: anti-KRAS G12D mTCR PBL | Phase 1|Phase 2 |
Drug: Cyclophosphamide, Fludarabine, Aldesleukin | |||||
NCT03412877 | Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer | unspecified | Endocrine Tumors|Non-Small Cell Lung Cancer|Ovarian Cancer(and 4 more…) | Biological: Individual Patient TCR-Transduced PBL | Phase 2/Recruiting |
Drug: Cyclophosphamide, Fludarabine, Aldesleukin, Pembrolizumab (KEYTRUDA) | |||||
NCT03190941 | Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients | KRAS G12V | Pancreatic Cancer |Gastric Cancer |Gastrointestinal Cancer|Colon Cancer|Rectal Cancer | Biological: Anti-KRAS G12V mTCR PBL | Phase 1|Phase 2/Recruiting |
Drug: Cyclophosphamide,Fludarabine,High-dose Aldesleukin | |||||
NCT00704938 | Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer | P53 | Kidney Cancer|Melanoma (Skin)|Unspecified Adult Solid Tumor,Protocol Specific | Biological: aldesleukin, anti-p53 T-cell receptor-transduced peripheral blood lymphocytes, autologous dendritic cell-adenovirus p53 vaccine,filgrastim | Phase 2 |
Drug: cyclophosphamide,fludarabine phosphate | |||||
NCT00393029 | Phase II Study of Metastatic Cancer That Overexpresses P53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes | P53 | Metastatic cancer | Biological: anti-protein 53 or tumor protein 53 (p53) T-cell receptor transduced peripheral blood lymphocytes, aldesleukin,filgrastim | Phase 2/Completed |
Drug: cyclophosphamide,fludarabine phosphate | |||||
NCT03431311 | T Cell Receptor Based Therapy of Metastatic Colorectal Cancer | TGFβII (frameshitf) | Colorectal Cancer | Biological: Adoptive Cell Therapy | Phase 1|Phase 2/Terminated |
NCT04102436 | Non-Viral TCR Gene Therapy | Unspecified | Glioblastoma|Non-Small Cell Lung Cancer|Breast Cancer|Gastrointestinal/Genitourinary Cancer|Ovarian Cancer | Biological: Sleeping Beauty Transposed PBL | Phase 2/Suspended |
Drug: Fludarabine,Cyclophosphamide,Aldesleukin | |||||
NCT03891706 | Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors | unspecified | Solid Tumor | Drug: tumor-specific TCR-T cells; Interleukin-2 | Phase1/Recruiting |