CLDN 18.2 chimeric antigen receptor T cells Clinical research plan for the treatment of recurrent or refractory pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Targeting CLDN 18.2 Car-T injection
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGOverall Response rate(ORR)
the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Time frame: 1month
Progression free survival(PFS)
Survival witouth observed progression at 2 years
Time frame: 1 years
Disease Control Rate(DCR)
DCR (CR+PR+SD) by RECIST v1.1
Time frame: 1 years
Duration of Response (DOR)
DOR was defined as the time from the first documented a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) to progressive disease (PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.
Time frame: 1 years
Overal survival (OS)
survival at 5 years
Time frame: 5 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
AEs according to CTCAE v 5.0.
Time frame: 1 year
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