Pilot Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer
Stopped early · Phase 1
Conditions studied: Pancreatic Cancer
In brief
This is a study in which pancreatic cancer patients receive a combination therapy with CART-meso cells and CART19 cells administered at 3 days after one dose of cyclophosphamide. CART-meso cells are patients' own T cells that were modified in the laboratory to express a receptor specific to the mesothelin protein. CART19 cells are patients' own T cells that were modified in the laboratory to express a receptor specific to a protein called CD19. The CD19 protein is expressed on white blood B cells. CART19 cells are expected to attack the B cells and impede the antibody response against CART-meso cells. The investigators hypothesize that this combination therapy may prolong the duration of CART-meso cells in the body. Additionally, one dose of cyclophosphamide may enhance engraftment and persistence of CART cells.
Key facts
- Study ID
- NCT02465983
- Run by
- University of Pennsylvania
- People needed
- 4
- Starts
- 2015-05-01
- Expected to finish
- 2017-11-01
- Last updated by the study team
- 2019-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent
- Unresectable or metastatic pancreatic cancer
- Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease
- 18 years of age and older
- ECOG performance status of 0 or 1
- Life expectancy greater than 3 months
- Satisfactory organ and bone marrow function
- Meets blood coagulation parameters
- Male and Female subjects of reproductive potential agree to use approved contraceptive methods
You may not qualify if…
- Participation in a therapeutic investigational study within 4 weeks prior to the screening visit
- Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion
- Active invasive cancer other than pancreatic cancer
- HIV, HCV, or HBV infections
- Active autoimmune disease requiring immunosuppressive therapy within 4 weeks prior to screening visit, with exception of thyroid replacement
- Ongoing or active infection
- Planned concurrent treatment with systemic high dose corticosteroids
- Patients requiring supplemental oxygen therapy
- Prior therapy with gene modified cells
- Previous experimental therapy with SS1 moiety, murine or chimeric antibodies
- History of allergy to murine proteins
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
- Clinically significant pericardial effusion, CHF, or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study
- Pregnant or breastfeeding women
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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