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. 2019 Feb 12;9:56. doi: 10.3389/fonc.2019.00056

Table 1.

Clinical trials involving CAR-based immunotherapy in pancreatic cancer from www.clinicaltrials.gov.

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.