Autologous Redirected RNA Meso CAR T Cells for Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01897415|
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : September 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Subjects With Metastatic Pancreatic Ductal Adenocarcinoma (PDA)||Biological: Autologous T cells transfected with chimeric anti-mesothelin immunoreceptor SS1||Phase 1|
This phase I study is being conducted to establish safety and feasibility of intravenous (IV) RNA mesothelin re-directed autologous T cell administration in patients with chemotherapy-refractory metastatic pancreatic cancer.
Subjects will be enrolled serially. For subject safety, the preceding subject must have completed therapy and be 28 days from their last infusion before the next subject can be treated.. Subjects will be treated with IV administration of 1 to 3e8/m2 RNA CAR T cells three times weekly (M-W-F) for three weeks.
Main eligibility criteria: Subjects with metastatic pancreatic ductal adenocarcinoma (PDA) who have chemotherapy-refractory disease. Inclusion criteria include patients older than 18 years of age diagnosed with metastatic PDA with ECOG 0-1 performance status and 3 month expected survival. Exclusion criteria include a pericardial effusion, active autoimmune disease requiring immunosuppressive therapy, active anti-coagulation therapy, known HIV or HTLV I/II positivity, prior treatment with murine monoclonal antibodies or history of allergy to murine proteins.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial of Autologous Mesothelin Re-directed T Cells in Patients With Chemotherapy Refractory Metastatic Pancreatic Cancer|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||March 2017|
Experimental: Autologous T cells
Autologous T cells transfected with chimeric anti-mesothelin immunoreceptor SS1
Biological: Autologous T cells transfected with chimeric anti-mesothelin immunoreceptor SS1
- Number of Adverse Events [ Time Frame: Day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897415
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Gregory Beatty, MD||Abramson Cancer Center of the University of Pennsylvania|