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A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for R/R B-NHL.
Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
Full description
Subjects with relapsed and refractory B-cell non-Hodgkin's lymphoma would be selected if subjects meet all criteria evaluated by physical exams, blood tests, electrocardiograph, computedtomography (CT)/magnetic resonance Imaging(MRI)/positron emission tomography(PET), tumor assessments, etc. Subjects would be hospitalized to receive the infusion of CD19 CAR+ T cells after lymphodepleting regimen, with the observation and evaluation of efficacy and safety.
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Inclusion and exclusion criteria
Inclusion Criteria:Subjects with relapsed/refractory B-cell non-Hodgkin's lymphoma
Age≥18 years old,gender is not limited;
Expected survival > 12 weeks;
ECOG score 0-2;
B-cell non-Hodgkin's lymphoma confirmed by cytology or histopathology according to the 2016 World Health Organization (WHO) classification and diagnostic criteria, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed filter Alveolar lymphoma (TFL) and high-grade B-cell lymphoma (HGBCL);
Pathology demonstrated that B-cell non-Hodgkin's lymphoma and who meet one of the following conditions:
The venous access required for collection can be established and leukepheresis can be carried according to the judgement of investigators, satisfying hemoglobin≥80g/L, neutrophils ≥1.0×10^9/L, platelets ≥75×10^9 / L;
According to the Lugano 2014 criteria, there should be at least one measurable tumor lesion;
Liver, kidney and cardiopulmonary functions meet the following requirements:
Able to understand and sign the Informed Consent Document.
Exclusion Criteria:Any one of the following conditions cannot be selected as a subject:
Primary purpose
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100 participants in 1 patient group
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Central trial contact
Xuedong Sun, M.D.
Data sourced from clinicaltrials.gov
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