CART-meso in Mesothelin Expressing Cancers (NCT02159716) | Clinical Trial Compass
CompletedPhase 1
CART-meso in Mesothelin Expressing Cancers
United States19 participantsStarted 2014-06
Plain-language summary
Phase I study to establish safety and feasibility of intravenously administered lentiviral transduced CART-meso cells administered with and without cyclophosphamide in a 3+3 dose escalation design in patients with metastatic pancreatic cancer, serous epithelial ovarian cancer, or pleural mesothelioma. Dose: 1-3xE7 /mE2 (Cohort 1 and 2) and 1-3xE8 /mE2 (Cohort 3 and 4 ) CAR+ T cells by intravenous route. In the event of 2 DLTs at each dose level, we will dose deescalate by 10-fold.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed cancer (one of the following):
* Metastatic pancreatic adenocarcinoma.
* Persistent or recurrent serous epithelial ovarian cancer or primary peritoneal carcinoma
* Malignant pleural mesothelioma (histologically confirmed epithelial)
* Failure of at least one prior standard of care chemotherapy for advanced stage disease.
* Subjects must have measureable disease as defined by RECIST 1.1 criteria or modified RECIST criteria.
* Patients \> 18 years of age.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy \> 3 months.
* Satisfactory organ and bone marrow function as defined by the following (of note, the minimal blood counts should be in the absence of transfusion or cytokine support):
i. Absolute neutrophil count \> 1,000/μl ii. Platelets \>75,000/μl iii. Hemoglobin \> 9 g/dL iv. Bilirubin \< 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor v. Creatinine \< 1.5x the institutional normal upper limit vi. Albumin ≥2 vii. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 5x the institutional normal upper limit viii. Cardiac ejection fraction of \>55% as measured by resting echocardiogram, with no 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 is therapeutically anti-coagul…