Pilot Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer
This trial is active, not recruiting.
|Treatments||cart-meso-19 t cells, cyclophosphamide|
|Sponsor||University of Pennsylvania|
|Collaborator||University of California, San Francisco|
|Start date||May 2015|
|End date||September 2017|
|Trial size||12 participants|
|Trial identifier||NCT02465983, CART-meso-19, UCSF CC144520, UPCC 19214|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Safety of IV administration of CART-meso-19 with cyclophosphamide as lymphodepleting chemotherapy in patients with pancreatic cancer using the NCI CTCAE v4.03 criteria
time frame: 24 months
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - 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
|Official title||Pilot Study of Autologous T-cells Redirected to Mesothelin and CD19 With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer|
|Principal investigator||Andrew Ko|
|Description||Immunotherapy is a novel and promising approach for the treatment of solid tumors; immunotherapy with chimeric antigen receptor (CAR) T cells (CART cells) in particular has the potential advantage of targeted therapies that can invoke a rapid tumor response, and the advantage of long-lived responses that are the hallmark of engagement of the adaptive immune system such as memory T cells. This is a single arm, open-label, phase I study to determine the safety and feasibility of combination CART-meso cells (autologous T cells lentivirally transduced to express anti-mesothelin scFv fused to TCRζ and 4-1BB costimulatory domains) and CART19 cells (autologous T cells lentivirally transduced to express a humanized anti-CD19 scFv fused to TCRζ and 4-1BB costimulatory domains) in patients with pancreatic cancer following lymphodepletion with cyclophosphamide.|
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