Phase
Condition
Pancreatic Disorders
Pancreatitis
Pancreatic Cancer
Treatment
huCART-meso cells
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
- Inclusion Criteria
Patients with the following diagnoses:
Cohorts 1 and -1: Histologically confirmed unresectable or metastaticpancreatic adenocarcinoma
Cohort 2: Histologically confirmed unresectable or metastatic pancreaticadenocarcinoma; and either cytologically-proven ascites or knownperitoneal disease on radiologic imaging.
Cohort 3 - 4: Histologically confirmed unresectable or metastaticpancreatic adenocarcinoma with liver metastases as confirmed by pathologyor radiographic imaging.
INCLUSION CRITERIA HAS BEEN RETIRED
Prior treatment requirements:
Cohorts 1 - 3: Failure of at least one prior standard of care chemotherapyfor advanced stage disease.
Cohort 4: At lease stable disease on the first-line standard of carechemotherapy for advanced stage disease.
Cohorts 1-3 and -1: Subjects must have measurable disease as defined by RECIST 1.1 criteria.
Patients ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Satisfactory organ and bone marrow function as defined by the following: i. Absolute neutrophil count ≥ 1,000/μl ii. Platelets ≥75,000/μl iii.Hemoglobin ≥ 8 g/dL iv. Direct bilirubin ≤ 2.0 mg/dl unless the subject hasGilbert's disease syndrome (≤ 3.0 mg.dl) v. Creatinine ≤ 1.5x the institutionalnormal upper limit vi. Albumin ≥ 2 vii. Serum alanine aminotransferase (ALT) oraspartate aminotransferase (AST) ≤5x the institutional normal upper limit viii.Cardiac ejection fraction of ≥40% as measured by resting echocardiogram, withno clinically significant pericardial effusion.
Blood coagulation parameters: PT such that international normalized ratio (INR)is ≤ 1.5 and a PTT ≤ 1.2 time the upper limit of normal unless the patient istherapeutically anti-coagulated for history of cancer-related thrombosis andhas stable coagulation parameters.
Provides written informed consent.
Subjects of reproductive potential must agree to use acceptable birth controlmethods
Exclusion
- Exclusion Criteria:
EXCLUSION CRITERIA HAS BEEN RETIRED
Active invasive cancer other than pancreatic adenocarcinoma. Patients withactive non-invasive cancers (such as non-melanoma skin cancer, superficialcervical and bladder cancer, or prostate cancer with PSA level < 1.0) are notexcluded.
HIV infection
Active hepatitis B or hepatitis C infection
Active autoimmune disease (including but not limited to: systemic lupuserythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiplesclerosis, inflammatory bowel disease, etc.) requiring immunosuppressivetherapy within 4 weeks prior to eligibility confirmation byphysician-investigator, with the exception of thyroid replacement.
Patients with ongoing or active infection.
Dependence on systemic steroids or immunosuppressant medications.
Patients requiring supplemental oxygen therapy.
Prior therapy with lentiviral gene modified cells.
History of allergy or hypersensitivity to study product excipients (human serumalbumin, DMSO, and Dextran 40)
Any clinically significant pericardial effusion, Class II-IV cardiovasculardisability according to the New York Heart Association Classification or othercardiovascular condition that would preclude assessment of mesothelin inducedpericarditis or that may worsen as a result of toxicities expected for thisstudy. This determination will be made by a cardiologist if cardiac issues aresuspected.
Any clinically significant pleural or peritoneal effusion that cannot bedrained with standard approaches. An indwelling drainage device placed prior toeligibility confirmation by physician-investigator is acceptable.
Pregnant or breastfeeding women.
EXCLUSION CRITERIA HAS BEEN RETIRED
EXCLUSION CRITERIA HAS BEEN RETIRED
Patients with significant lung disease as follows:
Patients with radiographic evidence of greater than lobar lymphangiticpulmonary involvement, greater than lobar bronchial wall thickening suggestiveof peribronchial lymphatic disease extension, and/or evidence of extensivebilateral parenchymal metastatic burden. Note: "Greater than lobar" = "in morethan 1 lobe".
Patients with radiographic and/or clinical evidence of active radiationpneumonitis.
Patients with radiographic evidence of underlying interstitial lung disease,including evidence of unresolved drug toxicity from any agent (e.g.chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc)
Patients with radiographic evidence of significant pleural effusion that is notreadily amenable to minimally invasive drainage.
Cohort 3 and 4 Subjects Only: Patients with a contraindication to IV contrast.
Study Design
Study Description
Connect with a study center
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
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