This study is designed to monitor all patients exposed to CD19 CAR-T expressing IL7 and CCL19 for 5 years following infusion, to assess their long-term efficacy, including the CAR-vector persistence, the normal immunity rebuilding and the risk of delayed adverse events (AEs).
Patients are enrolled following completion from the early clinical study of CD19-7X19 CAR-T treatment ( NCT03258047) and will be followed for 5 years post treatment from the last treatment. They will be monitored for safety and efficacy with the primary treatment protocols for the protocol defined duration. This long-term following up study allow an interim analysis to evaluate the outcomes of the study when it arrives in 2 years Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.
Study Type
OBSERVATIONAL
Enrollment
39
A fourth generation CD19 targeting CAR-T expressing IL7 and CCL19
Hui Liu
Hangzhou, State..., China
Evaluate the efficacy of CD19-IL7/CCL19 CAR-T
Evaluate the efficacy of CD19-IL7/CCL19 CAR-T including duration of response, progression-free survival, overall surviva and objective response rate (CR + PR) .
Time frame: 5 years
Evaluate the persistence of CAR-T cells
Levels and persistence of CAR+ T cells in serum samples
Time frame: 5 years
Evaluate the incidence of adverse events
The incidence of CRS and CRES; Levels and persistence of cytokines in serum samples;Proportion of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death ;B- and T- lymphocyte count;
Time frame: 5 years
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