This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. 20 patients were enrolled. Primary objective is to explore the safety. The secondary objective is to explore the efficacy.
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. All together 20 patients were enrolled. Primary objective is to explore the safety including the complication of cytokine release syndrome, CRES, pancytopenia and infection. The secondary objective is to explore the efficacy. We will also detect CAR-T cell expansion dynamics in blood and cerebral fluid and compare the difference.
Study Type
OBSERVATIONAL
Enrollment
20
CD19 targeted CAR-T treatment
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGthe First Affiliated Hospital,School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGAdverse events that related to treatment
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Time frame: 2 years
The response rate of CAR-T treatment in patients with relapse/refractory B cell malignancies involved in CNS that treated by CD19 CAR-T cells therapy
The response rate of BCMA CAR-T treatment will be recorded and assessed according to WHO criteria
Time frame: 6 months
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