Table 1.
Selected CAR-T clinical trials targeting solid tumor-associated antigens
| Antigen | CAR design | Identifier | Disease condition | Phase | Status | Sponsor | Notes | Ref |
|---|---|---|---|---|---|---|---|---|
| FR-α | 1st (FcRγ) | NCT00019136 | Ovarian cancer | I | Completed | National Cancer Institute | [35] | |
| 4th | NCT03185468 | Bladder cancer, urothelial carcinoma bladder | I/II | Recruiting | Shenzhen Geno-immune Medical Institute | |||
| CAIX | 1st | DDHK97-29/P00.0040C | Renal cell carcinoma | I/II | Completed | Erasmus University Medical Center | First clinical study of its nature in Europe | [36, 115–117] |
| L1-CAM | 2nd and 3 | NCT02311621 | Neuroblastoma | I | Recruiting | Seattle Children’s Hospital | ||
| 1st | NCT00006480 | Neuroblastoma | I | Completed | Fred Hutchinson Cancer Center | [38] | ||
| MSLN | NA | NCT01583686 | Cervical, pancreatic, ovarian, and lung cancer, mesothelioma | I/II | Recruiting | National Cancer Institute | [118] | |
| 2nd | NCT01355965 | Malignant pleural mesothelioma | I | Completed | University of Pennsylvania | Intravenous (IV) administration of RNA mesothelin redirected autologous T cell | [39, 40] | |
| 2nd | NCT02159716 | Pancreatic, ovarian cancer, malignant epithelial pleural mesothelioma | I | Completed | University of Pennsylvania | |||
| 2nd | NCT01897415 | Metastatic pancreatic ductal adenocarcinoma | I | Completed | University of Pennsylvania | Intravenous (IV) administration of RNA mesothelin redirected autologous T cell | [41] | |
| 2nd | NCT02465983 | Pancreatic cancer | I | Completed | University of Pennsylvania | |||
| 2nd | NCT02414269 | Mesothelioma, lung and breast cancer | I | Recruiting | MSKCC | iCasp9M28z T cell | ||
| 2nd | NCT02706782 | Pancreatic cancer | I | Recruiting | Shanghai GeneChem Co., Ltd. | Vascular intervention-mediated CAR-T infusion | ||
| NA | NCT03030001 | Solid tumors | I/II | Recruiting | Ningbo Cancer Hospital | PD-1 antibody expressing mesothelin-specific CAR-T cells | ||
| NA | NCT03182803 | Advanced solid tumors | I/II | Recruiting | Shanghai Cell Therapy Research Institute | CTLA-4/PD-1 antibodies expressing mesoCAR-T | ||
| HER2 | NA | NCT00924287 | HER2-positive sarcoma | I/II | Terminated | National Cancer Institute | [21, 119] | |
| 2nd | NCT00902044 | HER2-positive sarcoma | I/II | Recruiting | Baylor College of Medicine | [28] | ||
| NA | NCT01935843 | HER-2 positive solid tumors | I/II | Recruiting | Chinese PLA General Hospital | [42] | ||
| 2nd | NCT02547961 | Breast cancer | I/II | Completed | Fuda Cancer Hospital | |||
| 2nd | NCT02442297 | Glioblastoma | I | Recruiting | Baylor College of Medicine | |||
| 2nd | NCT01109095 | Glioblastoma multiforme | I | Ongoing | Baylor College of Medicine | Genetically modified HER.CAR CMV-specific CTLs | [43] | |
| 2nd | NCT00889954 | HER2 positive malignancies | I | Ongoing | Baylor College of Medicine | TGFbeta dominant-negative receptor (DNR) expressing EBV specific lymphocytes | ||
| EGFR | 2nd | NCT01869166 | Advanced EGFR-positive solid tumors | I/II | Recruiting | Chinese PLA General Hospital | [44] | |
| NA | NCT03182816 | Advanced solid tumor | I/II | Recruiting | Shanghai Cell Therapy Research Institute | Anti-CTLA-4/PD-1 expressing EGFR-CAR-T | ||
| NA | NCT02873390 | Advanced solid tumor | Recruiting | Ningbo Cancer Hospital | PD-1 antibody expressing CAR-T cells | |||
| NA | NCT02862028 | Advanced solid tumor | I/II | Recruiting | Shanghai International Medical Center | PD-1 antibody expressing CAR-T cells | ||
| EGFRvIII | 3rd | NCT01454596 | Glioma, glioblastoma, brain cancer | I/II | Recruiting | National Cancer Institute | [120] | |
| NA | NCT02209376 | EGFRvIII positive glioma | I | Ongoing | University of Pennsylvania | |||
| NCT03170141 | Glioblastoma multiforme | I/II | Recruiting | Shenzhen Geno-immune Medical Institute | 4SCAR-IgT cells producing PD1 and PD-L1 antibodies | |||
| IL13Rα2 | 1st | NCT00730613 | Glioblastoma | I | Completed | City of Hope Medical Center | CAR expresses the Hy/TK selection/suicide fusion protein | [30] |
| 2nd | NCT02208362 | Glioblastoma | I | Recruiting | City of Hope Medical Center | Hinge-optimized | ||
| 1st | NCT01082926 | Glioblastoma | I | Completed | City of Hope Medical Center | T cells modified to express HyTK and to be resistant to glucocorticoids, in combination with interleukin-2 | ||
| CEA | 2nd | NCT01373047 | Liver metastases | I | Completed | Roger Williams MC | [31, 121] | |
| 2nd | NCT02416466 | Liver metastases | I | Ongoing | Roger Williams MC | [122] | ||
| 2nd | NCT02349724 | Lung, colorectal, gastric, breast, and pancreatic cancer | I | Recruiting | Southwest Hospital | [123] | ||
| 2nd | NCT02862704 | Liver metastases | I/II | Recruiting | Xijing Hospital | MG7 specific CAR-T, which is a glycosylated protein of CEA | ||
| NA | NCT02850536 | Liver metastases | I | Recruiting | Roger Williams MC | delivered via the hepatic artery using the Surefire Infusion System (SIS) | ||
| NA | NCT00004178 | Solid tumor | I | Completed | Roger Williams MC | |||
| 1st | NCT01212887 | Adult solid tumor, | I | Terminated | Cancer Research UK | MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes | ||
| GD2 | 1st | NCT00085930 | Neuroblastoma | I | Ongoing | Baylor College of Medicine | 14g2a.zeta chimeric receptor-transduced autologous EBV specific cytotoxic T lymphocytes (EBV-CTL) w/o lymphodepletion | [46, 124] |
| 3rd | NCT01822652 | Neuroblastoma | I | Ongoing | Baylor College of Medicine | iC9-GD2-CD28-OX40 (iC9-GD2) T cells | [125] | |
| 3rd | NCT01953900 | Sarcomas | I | Ongoing | Baylor College of Medicine | [126] | ||
| 3rd | NCT02439788 | Neuroblastoma | I | Withdrawn | Baylor College of Medicine | 3rd generation GD2 specific CAR and inducible caspase 9 safety switch transduced autologous natural killer T cells | ||
| NA | NCT01460901 | Neuroblastoma | I | Completed | Children’s Mercy Hospital, Kansas | [125] | ||
| 3rd | NCT02107963 | Osteosarcoma, neuroblastoma, Melanoma | I | Completed | National Cancer Institute | [127] | ||
| 4th | NCT02765243 | Neuroblastoma, effects of immunotherapy | II | Recruiting | Zhujiang Hospital | |||
| 4th | NCT02992210 | Solid tumor | I/II | Recruiting | Shenzhen Geno-immune Medical Institute | 4th generation CAR (4SCAR) fused with an inducible apoptotic caspase 9 domain | ||
| MUC1 | NA | NCT02617134 | Glioma, colorectal and gastric carcinoma | I/II | Recruiting | PersonGen BioTherapeutics | ||
| 3rd | NCT02587689 | NSCLC, hepatocellular, pancreatic, and breast carcinoma | I/II | Recruiting | PersonGen BioTherapeutics | [29] | ||
| NA | NCT03179007 | Advanced solid tumor | Recruiting | Ningbo Cancer Hospital | Anti-CTLA-4/PD-1 expressing MUC1-CAR-T | |||
| PSMA | 2nd | NCT01140373 | Prostate cancer | I | Ongoing | MSKCC | ||
| NA | NCT01929239 | Prostate cancer | I/II | Suspended (funding) | Roger Williams MC | [128] | ||
| 1st | BB-1ND12084 | Prostate cancer | I | Roger Williams MC | [48] | |||
| 4th | NCT03185468 | Bladder cancer, urothelial carcinoma bladder | I/II | Recruiting | Shenzhen Geno-immune Medical Institute | |||
| PSCA | NA | NCT03198052 | Lung cancer | I | Recruiting | Guangzhou Medical University | ||
| NA | NCT02744287 | Pancreatic cancer | I | Recruiting | Bellicum Pharmaceuticals | |||
| FAP | 2nd | NCT01722149 | Malignant pleural mesothelioma | I | Recruiting | University of Zurich | [32] | |
| CD133 | 1st, 2nd | NCT02541370 | CD133-positive malignancies | I | Recruiting | Chinese PLA General Hospital | [45] | |
| cMet | NA | NCT01837602 | Breast | I | Ongoing | University of Pennsylvania | cMet RNA CAR-T cells | [47] |
| 2nd | NCT03060356 | Malignant melanoma, breast cancer | I | Recruiting | University of Pennsylvania | cMet RNA CAR-T cells | ||
| EphA2 | NA | NCT02575261 | Glioma | I/II | Completed | Fuda Cancer Hospital | ||
| GPC3 | 2nd | NCT02715362 | Hepatic carcinoma | I/II | Recruiting | Shanghai GeneChem Co., Ltd. | Administration by transcatheter arterial infusion (TAI) method | |
| NCT02723942 | Hepatocellular carcinoma | I/II | Completed | Fuda Cancer Hospital, Guangzhou | ||||
| NCT02876978 | Lung squamous cell carcinoma | I | Recruiting | Carsgen Therapeutics, Ltd. | ||||
| NCT03130712 | Hepatocellular carcinoma | I/II | Recruiting | Shanghai GeneChem Co., Ltd. | ||||
| 3rd | NCT03198546 | Hepatocellular carcinoma | I | Recruiting | Guangzhou Medical University | |||
| VEGFR-II | NA | NCT01218867 | Melanoma, renal cancer | I/II | Completed | National Cancer Institute | ||
| ROR1 | NA | NCT02706392 | Breast, lung carcinoma | I | Recruiting | Fred Hutchinson Cancer Center | [129] | |
| EpCAM | NA | NCT02729493 | Liver neoplasms | Recruiting | Sinobioway Cell Therapy Co., Ltd. | |||
| NA | NCT02725125 | Stomach neoplasms | Recruiting | Sinobioway Cell Therapy Co., Ltd. | ||||
| 2nd | NCT02915445 | Malignant neoplasm of nasopharynx, breast Cancer | I | Recruiting | Sichuan University | |||
| 2nd | NCT03013712 | Solid tumors | I/II | Recruiting | First Affiliated Hospital of Chengdu Medical College | |||
| MUC16ecto | 2nd | NCT02498912 | Solid tumors | I | Recruiting | MSKCC | T cells genetically engineered to secrete IL-12 | [130] |
Representative clinical trials using CAR-T to treat solid tumors are grouped based on the tumor-associated antigens they are targeting. Trial-related information were mainly collected from published results and ClinicalTrials.gov
Abbreviations: CAIX carboxyanhydrase-IX, CEA carcinoembryonic antigen, cMET hepatocyte growth factor receptor, EGFR epidermal growth factor receptor, EpCAM epithelial cell adhesion molecule, EphA2 EPH receptor A2, FAP fibroblast activation protein α, GD2 disialoganglioside, GPC3 glypican-3, HER2 human epidermal growth factor receptor-2, L1-CAM L1 cell adhesion molecule, MSLN mesothelin, MUC1 mucin, NA not applicable, PSMA prostate-specific membrane antigen, ROR1 receptor tyrosine kinase-like orphan receptor 1, VEGFR vascular endothelial growth factor receptor