Pilot Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer

• Status: Terminated
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: University of California, San Francisco
• Treatments: Cyclophosphamide

Criteria

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