Table 1.
Target antigen | Sponsor/collaborator | Cancer type | Status/estimated completion date | Number of patients | Trial ID | Notes |
---|---|---|---|---|---|---|
MSLN | National Cancer Institute, USA | Pancreatic cancer Cervical cancer Ovarian cancer Mesothelioma Lung cancer |
Recruiting/December, 2029 | 136 estimated | NCT01583686 | Intravenous infusion of retroviral transduced MSLN-CAR T cells and low dose IL-2 with cyclophosphamide and fludarabine preconditioning. |
University of Pennsylvania, USA | Pancreatic cancer | Active, not recruiting/September, 2021 | 18 estimated | NCT03323944 | 1–3 × 107/m2 (Cohort 1) or 1–3 × 108/m2 (Cohort 2 and 3) lentiviral transduced MSLN-CAR T cells with/without cyclophosphamide preconditioning. | |
Shanghai Gene Chem Co., Ltd./Shanghai Cancer Hospital, China | Metastatic pancreatic cancer | Unknown/July, 2018 | 20 estimated | NCT02959151 | Intratumor injection or i.v. at one dose of 1.25~4 × 107 CAR+ lentiviral transduced MSLN-CAR T cells/cm 3 tumor bulk. | |
University of Pennsylvania, USA | Metastatic PDAC | Completed/March 2017 | 16 actual | NCT01897415 | 1–3 × 108/m2 RNA transfected MSLN-CAR T cells i.v. injected three times weekly for up to 3 weeks. No cytokine release syndrome, neurologic symptoms or dose-limiting toxicities reported. One patient has a response in the live, but no activity in the primary tumor (37). | |
University of Pennsylvania, USA | Metastatic PDAC Epithelial ovarian cancer Malignant epithelial pleuralmesothelioma | Completed/November, 2015 | 19 actual | NCT02159716 | 1–3 × 107 and 1–3 × 108/m2 lentiviral transduced MSLN-CAR T cells i.v. injected with or without cyclophosphamide preconditioning. Safe in patients with recurrent serious ovarian cancer. CAR T cells expanded in the blood of all patients. One patient had clearance of pleural effusion (104). |
|
Chinese PLA General Hospital, China | Malignant mesothelioma Pancreatic cancer Ovarian tumor Triple negative breast cancer Endometrial cancer Other MSLN+ tumors |
Unknown/November 2018 | 20 estimated | NCT02580747 | Retroviral transduced MSLN-CAR T cells. | |
China Meitan General Hospital/Marino Biotechnology Co., Ltd. China | Mesothelin+ tumors | Recruiting/August 2019 | 20 estimated | NCT02930993 | i.v. infusion with 5 × 104-1 × 107/kg MSLN-CAR T cells in a three-day split-dose regime. Cyclophosphamide preconditioning. | |
University of Pennsylvania, USA | Pancreatic cancer Mesothelioma | Completed/September 2017 | 18 actual | NCT01355965 | Three infusions of 1 × 108-1 × 109 mRNA MSLN-CAR T cells every other day for 2-cycle of three infusions. The pancreatic patient was given eight doses i.v. infusions and two intratumor injections. Anti-tumor effect observed and no overt toxicities (36). |
|
University of Pennsylvania/University of California, USA | Pancreatic cancer | Completed/November, 2017 | 4 actual | NCT02465983 | i.v. infusion of 1–3 × 107/m2 or 1 × 108/m2 combined lentiviral transduced MSLN-CAR T cells and CD19-CAR T cells (to deplete B cells and impede the antibody response against MSLN CAR T cells) with cyclophosphamide preconditioning. | |
First Affiliated Hospital of Wenzhou Medical University, China | Pancreatic cancer | Active, not recruiting/October, 2020 | 10 estimated | NCT03497819 | Pancreatic arterial or i.v. infusion of lentiviral transduced MSLN-CAR T cells and CD19 CAR T cells with cyclophosphamide preconditioning. | |
Shanghai GeneChem Co., Ltd. China | Pancreatic cancer | Unknown/September 2018 | 30 estimated | NCT02706782 | Transcatheter arterial infusion of 1–10 × 106 MSLN-CAR+ T cells/kg. Cyclophosphamide preconditioning. |
|
MSLN, PSCA, CEA, HER2, MUC1, EGFRvIII and other targets | First Affiliated Hospital of Harbin Medical University/Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd. China | Pancreatic cancer | Recruiting/June 2019 | 10 estimated | NCT03267173 | A single dose of 107 /kg CAR T cells administered i.v. |
Cancer Research UK, UK | Pancreatic cancer Breast cancer Colorectal cancer Gastric cancer Lung cancer Ovarian cancer Unspecified adult solid tumor |
Terminated/April 2010 | 14 actual | NCT01212887 | The pancreatic cancer patient received 109-5 × 1010 retroviral transduced CEA CAR T cells i.v. and seven doses IL-2 with cyclophosphamide and fludarabine preconditioning. All patients had adverse events with grade ≤ 2 and lack of prolonged CAR T cell persistence led to the premature termination of the trial. No objective clinical response observed although serum CEA level reduced in the pancreatic cancer patient (47). |
|
CEA | Roger Williams Medical Centre/University of Colorado, USA | Liver metastases Pancreatic cancer |
Active, not recruiting/August, 2018 | 5 actual | NCT02850536 | Three hepatic artery infusions of CEA-CAR T cells delivered by the Surefire Infusion System at 1-week intervals. Low dose IL-2 for 4 weeks. |
Southwest Hospital, China | Pancreatic cancer Lung cancer Colorectal cancer Gastric cancer Breast cancer |
Recruiting/December, 2019 | 75 estimated | NCT02349724 | CEA-CAR T cells were well-tolerated in high doses with some efficacy reported in the colorectal cancer cohort (105). | |
Roger Williams Medical Center/Sirtex Medical, USA | Liver metastases | Active, not recruiting/January 2019 | 8 actual | NCT02416466 | Three doses of CEA-CAR T cells and 1 dose of Selective Internal Radiation Therapy (SIRT) with Yttrium-90 at 2-weeks intervals combined with low dose IL-2 for 6 weeks. | |
PSCA | Bellicum Pharmaceutical, USA | PDAC Gastric adenocarcinoma Prostate adenocarcinoma |
Recruiting/December, 2020 | 138 estimated | NCT02744287 | i.v. infusion of retroviral transduced PSCA CAR T cells (BPX-601) with rimiducid (a homodimerizing molecule that enhances BPX-601 activation). |
CD70 | National Cancer Institute, USA | Pancreatic cancer Renal cell cancer Breast cancer Melanoma Ovarian cancer |
Recruiting/January, 2028 | 113 estimated | NCT02830724 | i.v. infusion of retroviral transduced CAR T cells. The CAR consists of the CD70 receptor CD27. Cyclophosphamide and fludarabine preconditioning with high dose IL-2. |
MUC1 | PersonGen BioTherapeutics (Suzhou) Co., Ltd./The First People's Hospital of Hefei; Hefei Binhu Hospital, China | Pancreatic carcinoma Hepatocellular carcinoma Non-small cell lung cancer Triple-negative invasive breast carcinoma |
Unknown/October, 2018 | 20 estimated | NCT02587689 | |
PersonGen BioTherapeutics (Suzhou) Co., Ltd./The First People's Hospital of Hefei/Hefei Binhu Hospital, China | Pancreatic carcinoma Hepatocellular carcinoma Non-small cell lung cancer Triple negative invasive breast carcinoma Malignant glioma of brain Colorectal carcinoma Gastric carcinoma |
Unknown/July, 2018 | 10 estimated | NCT02839954 | Anti-MUC1 CAR-NK cells. | |
HER2 | Southwest Hospital, China | Pancreatic cancer Breast cancer Ovarian cancer Lung cancer Gastric cancer Colorectal cancer Glioma |
Recruiting/September, 2019 | 60 estimated | NCT02713984 | |
EpCAM | First Affiliated Hospital of Chengdu Medical College, China | Pancreatic cancer Colon cancer Esophageal carcinoma Prostate cancer Gastric cancer Hepatic carcinoma |
Recruiting/December, 2020 | 60 estimated | NCT03013712 | 1–10 × 106 lentiviral transduced EpCAM-CAR+ T cells/kg. Vascular interventional or endoscopy infusion. Precondition before CAR T cell infusion. |
Claudin 18.2 | CARsgen Therapeutics, Ltd., China | Pancreatic carcinoma Adenocarcinoma of esophagogastric junction |
Not recruiting/December, 2020 | 48 estimated | NCT03302403 | i.v. infusion. Fludarabine and cyclophosphamide preconditioning. |
Changhai Hospital/CARsgen Therapeutics, Ltd., China | PDAC Advanced gastric adenocarcinoma |
Recruiting/December 2021 | 24 estimated | NCT03159819 | i.v. infusion of lentiviral transduced CAR T cells with lymphodepletion preconditioning. | |
CD133 | Chinese PLA General Hospital, China | Pancreatic cancer Liver cancer Brain tumor Breast cancer Ovarian tumor Colorectal cancer Acute myeloid and lymphoid leukemias |
Unknown/October 2018 | 20 estimated | NCT02541370 | Retroviral transduced CD133-CAR T cells. |