This is a study in which pancreatic cancer patients receive a immunotherapy with CART-meso cells administered at 3 days after one dose of cyclophosphamide. CART-meso cells are patients' own T cells lentivirally transduced to express anti-mesothelin scFv fused to TCRζ and 4-1BB costimulatory domains.The lymphodepletion with cyclophosphamide may prolong the persistence of CART cells.
This study is being conducted to assess the safety and efficacy of immunotherapy with CART-meso cells in dose escalation design. The trial will begin in Cohort 1 and progress to Cohorts 2, depending upon dose limiting toxicity (DLT) assessment . Subjects will be enrolled serially, but infusions will be staggered to allow assessment of DLTs for determination of cohort progression, expansion, or dose de-escalation. Cohort 1 subjects will receive a single dose of 1-3x10\^7 /m\^2 lentiviral transduced CART-meso cells after conditioning chemotherapeutic regimen. Cohort 2 subjects will receive a single dose of 1-3x10\^8 /m\^2 lentiviral transduced CART-meso cells cells after conditioning chemotherapeutic regimen. Dose limiting toxicity is defined as any adverse reactions at level 3 or above that may be associated with CART-meso within 4 weeks after infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CART-meso is a 2nd CAR, with mesothelin as target protein, 4-1BB as co- stimulator. The infusion will be scheduled to occur 3 (±1) days after a single dose of 1.5 grams/m\^2 of cyclophosphamide, which will be administered according to standard procedures, Thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects.
Nanjing First Hospital
Nanjing, Jiangsu, China
RECRUITINGSafety of CART-meso infusion: number of adverse events
Number of Adverse Events evaluated with NCI CTC AE, version 4.0\[Safety evaluation\]
Time frame: 60 months
Clinical response of CART-meso
Number of patients with tumor response including overal remission ,complete ression,progression-free survival,progressive disease ,etc.
Time frame: 60 months
CAR-T cell detection
Detection of transferred T cells in peripheral blood or bone marrow using multi-parameter flow cytometer.
Time frame: 60 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.