Evaluate the safety and efficacy of mesothelin-targeting UCAR-T cells in the treatment of mesothelin-positive advanced pancreatic cancer
3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
CHT 102 : MSLN UCAR-T.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
RECRUITINGSafety and Tolerability
Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Time frame: 2 years
Objective response rate (ORR)
The total response rate after 90 days of treatment with study drug.
Time frame: At 4 weeks, and overall
Disease control rate (DCR)
The disease control rate after 90 days of treatment with study drug.
Time frame: At 4 weeks, and overall
Progress-free survival(PFS)
PFS will be assessed from the first CHT102 infusion to death from any cause or the first assessment of progression (Assessed based on RECIST criteria)
Time frame: 2 years
Overall survival (OS )
OS will be assessed from the first CHT102 infusion to death from any cause (Assessed based on RECIST criteria)
Time frame: 3 years
pharmacokinetics (PK)
Concentration levels of MSLN+ CAR-T cells
Time frame: 6 months
PD
Concentration levels of MSLN U CAR-T-related serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α, etal
Time frame: 6 months
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