Pancreatic Cancer Clinical Trial
Official title:
Pilot Study of Autologous Chimeric Antigen Receptor Cells Against Mesothelin and CD19 in Patients With Pancreatic Cancer
Verified date | April 2018 |
Source | First Affiliated Hospital of Wenzhou Medical Univeristy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pancreatic cancer patients receive chimeric antigen receptor (CAR) T cells against mesothelin (CARTmeso) or CD19 (CART19) cells administered at 3 days via pancreatic artery infusion or i.v. after preconditioning of cyclophosphamide. Both CART cells are autologous. CARTmeso cells target pancreatic cells which highly express mesothelin, while CART19 cells target tumor-associated B cells expressing cluster of differentiation antigen 19 (CD19) which are mostly immunosuppressive. The investigators hypothesize that this combination therapy may enhance the efficacy of CARTmeso cells in the body. Additionally, a medium dose of cyclophosphamide is used to enhance the engraftment of CART cells.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | October 31, 2020 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Signed informed consent - serum soluble mesothelin-related protein (SMRP) > 0.4 nanomolar/L - Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease - 18 years of age and =65 - Life expectancy greater than 3 months - Satisfactory organ and bone marrow function Exclusion Criteria: - Participation in a therapeutic investigational study within 4 weeks prior to the screening visit - Active invasive cancer other than pancreatic cancer - HIV, hepatitis B/C virus, or infections - Active autoimmune disease requiring immunosuppressive therapy within 4 weeks - Planned concurrent treatment with systemic high dose corticosteroids - Patients requiring supplemental oxygen therapy - Pregnant or breastfeeding women |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Wenzhou Medical Univeristy |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Percentage of Adverse Events (AEs) = grade 3 assessed through MedDra and CTCAE v4.03 [Time frame: from infusion to 3 month afterward] | Primary outcome is the percentage of adverse events (AEs) = grade 3. AEs are assessed through MedDra and CTCAE v4.03. Any patients who receive any dose of CART cells will be evaluated | From first infusion to 3 months afterward | |
Secondary | Overall Response Rate defined as any improvement measured by imaging following RECIST 1.1 [Time Frame: Day 14 and 1 month after infusion] | Secondary outcome is overall response rate. A response is defined as any improvement measured by imaging following RECIST 1.1. Only patients who receive infusions per protocol will be evaluated. | Day 14 and 1 month after infusion, or until patient withdraw consent or receive new therapy |
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