Status:
ACTIVE_NOT_RECRUITING
CAR T Cell Immunotherapy for Pancreatic Cancer
Lead Sponsor:
University of Pennsylvania
Conditions:
Pancreatic Cancer
Cancer of the Pancreas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase I study to establish the safety and feasibility of both intravenous administration and local delivery of lentiviral transduced huCART-meso cells in patients with histologically confirmed unresec...
Detailed Description
This is a Phase I study evaluating the safety and feasibility of lentiviral transduced huCART-meso cells in up to 4 cohorts. Lymphodepleting chemotherapy will not be utilized as part of the planned do...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients with the following diagnoses:
- Cohorts 1 and -1: Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma
- Cohort 2: Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma; and either cytologically-proven ascites or known peritoneal disease on radiologic imaging.
- Cohort 3 - 4: Histologically confirmed unresectable or metastatic pancreatic adenocarcinoma with liver metastases as confirmed by pathology or radiographic imaging.
- INCLUSION CRITERIA HAS BEEN RETIRED
- Prior treatment requirements:
- Cohorts 1 - 3: Failure of at least one prior standard of care chemotherapy for advanced stage disease.
- Cohort 4: At lease stable disease on the first-line standard of care chemotherapy 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 has Gilbert's disease syndrome (≤ 3.0 mg.dl) 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 ≥40% as measured by resting echocardiogram, with no 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 is therapeutically anti-coagulated for history of cancer-related thrombosis and has stable coagulation parameters.
- Provides written informed consent.
- Subjects of reproductive potential must agree to use acceptable birth control methods
- Exclusion Criteria:
- EXCLUSION CRITERIA HAS BEEN RETIRED
- Active invasive cancer other than pancreatic adenocarcinoma. Patients with active non-invasive cancers (such as non-melanoma skin cancer, superficial cervical and bladder cancer, or prostate cancer with PSA level \< 1.0) are not excluded.
- HIV infection
- Active hepatitis B or hepatitis C infection
- Active autoimmune disease (including but not limited to: systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) requiring immunosuppressive therapy within 4 weeks prior to eligibility confirmation by physician-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 serum albumin, DMSO, and Dextran 40)
- Any clinically significant pericardial effusion, Class II-IV cardiovascular disability according to the New York Heart Association Classification or other cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study. This determination will be made by a cardiologist if cardiac issues are suspected.
- Any clinically significant pleural or peritoneal effusion that cannot be drained with standard approaches. An indwelling drainage device placed prior to eligibility 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:
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- Patients with radiographic evidence of greater than lobar lymphangitic pulmonary involvement, greater than lobar bronchial wall thickening suggestive of peribronchial lymphatic disease extension, and/or evidence of extensive bilateral parenchymal metastatic burden. Note: "Greater than lobar" = "in more than 1 lobe".
- Patients with radiographic and/or clinical evidence of active radiation pneumonitis.
- 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 not readily amenable to minimally invasive drainage.
- 17\. Cohort 3 and 4 Subjects Only: Patients with a contraindication to IV contrast.
Exclusion
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03323944
Start Date
September 15 2017
End Date
December 1 2025
Last Update
October 9 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104