A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
This study is indicated for patients with CD19+ newly diagnosed high-risk large B-cell lymphoma. This study is an investigator-initiated, single-center, single-arm phase II clinical trial of rituximab, lenalidomide, and zanubrutinib (ZR2) with Sequential CAR-T cell as first-line therapy for newly diagnosed high-risk LBCL. Primary objective is to explore the efficacy and also safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Each subject receive CD19 CAR T-cells by intravenous infusion
The First Affiliated Hospital,College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGComplete remission rate after CD19 CAR-T cell therapy
Assessment of complete remission rate at 3 months after CD19 CAR-T cell therapy
Time frame: 3 months after CD19 CAR-T cell therapy
Overall response rate (ORR)
Assessment of ORR after ZR2 and CAR-T cell therapy
Time frame: After ZR2, 3 months after CAR-T cell therapy
Overall survival (OS)
From the start of treatment to death or the last visit
Time frame: Up to 2 years after CD19 CAR-T cells infusion
Progression-free survival (PFS)
From the start of the treatment to the occurrence of any event, including death, disease progression (any one occurs first), or the last visit
Time frame: Up to 2 years after CD19 CAR-T cells infusion
Duration of response (DOR)
among patients experiencing an objective response, defined as the time from the first objective response to events of disease progression or death from any cause
Time frame: Up to 2 years after CD19 CAR-T cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: Up to 2 years after CD19 targeted CAR T-cells infusion
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