This is a phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R/R Non-Hodgkins Lymphoma in China.
Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.
CD20 positive patients undergo corresponding targeted therapy.
Patients must have evaluable evidence of disease (according to Lugano 2014 standards).
≥ 18 years old.
The investigators judged patients with gastrointestinal lymph nodes and/or central nervous system involvement who may be at risk for CAR-T treatment.
Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease
Subject has used chemotherapy or radiotherapy within three days before the blood collection period.
Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).
Single group
IM19 CAR-T Cells
DrugIM19 CAR-T cells Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days
Objective Response Rate(ORR) at 90 days
The primary endpoint was ORR 90 days after IM19 infusion
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Beijing Immunochina Medical Science & Technology Co., Ltd.
Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborator
