PD1-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer
Clinical trial for the safety and efficacy of Non-viral programmed cell death protein-1(PD1) integrated anti-prostate-specific-membrane-antigen(PSMA) chimeric antigen receptor T(CART) cells in the treatment of Refractory Castrate-Resistant Prostate Cancer(CRPC)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
PD1-PSMA-CART cells will be given IV at split doses
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set.
Time frame: 28 days
Prostate specific antigen (PSA) response rate
proportion of patients with ≥50% PSA decline from baseline at any time point after therapy and maintained for ≥4weeks
Time frame: 180 days
Radiographic response rate by RECIST 1.1 & PCWG3
Proportion of patients with a best response of either complete response or partial response, assessed using Prostate Cancer Working group3(PCWG3) response criteria \& Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Time frame: 180 days
Number of persistent CART cells detected by Quantitative Real-time Polymerase Chain Reaction or flow cytometry
Number of persistent CART cells detected by Quantitative Real-time Polymerase Chain Reaction or flow cytometry
Time frame: 180 days
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