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 range
18 Years
Sex
ALL
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 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.