Autologous Redirected RNA Meso CAR T Cells for Pancreatic Cancer (NCT01897415) | Clinical Trial Compass
CompletedPhase 1
Autologous Redirected RNA Meso CAR T Cells for Pancreatic Cancer
United States16 participantsStarted 2013-07
Plain-language summary
This is a Phase I safety and feasibility study. Subjects will be enrolled serially. For subject safety, the preceding subject must have completed one cycle of therapy (28 days) before the next subject can be treated. Subjects will be treated with i.v. administration of 1 to 3e8 per meter squared RNA CAR T cells three times weekly (M-W-F) for three weeks.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed metastatic pancreatic adenocarcinoma.
* Patients greater than or equal to 18 years of age.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy greater than 3 months.
* Evidence of metastatic disease and failure of at least 1 prior chemotherapy for metastatic disease.
* Subjects must have measureable disease as defined by RECIST 1.1 criteria.
* Satisfactory organ and bone marrow function
* Blood coagulation parameters: PT such that international normalized ratio (INR) is less than or equal to 1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT less than or equal to 1.2 time the upper limit of normal.
* Subjects must have adequate venous peripheral access for apheresis. Patients must also have adequate venous access for subsequent modified CAR T cell administration which can be done through a central venous access (e.g. port for systemic chemotherapy)
* Ability to understand and the willingness to provide written informed consent.
* Short-term therapy for acute conditions not specifically related to pancreatic cancer is allowed if such therapy does not include immune modulating agents.
* Male and Female subjects agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) during the study and for 3 …