To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive diffuse large B-cell lymphoma and follicular lymphoma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
Participants with relapsed/refractory CD19-positive Diffuse Large B-cell Lymphoma and Follicular Lymphoma can participate if all eligibility criteria are met.Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI , and blood draws.Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 CAR+ T cells. Study procedures may be performed while hospitalized.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Autologous genetically modified anti-CD19 CAR transduced T cells
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGFudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe First Affilicated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGSafety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
Time frame: 2 years post infusion
Duration of CAR-positive T cells in circulation
Time frame: 2 years post infusion
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Time frame: 2 years post infusion
Overall remission rate including complete response and Partial response defined by the standard response criteria for malignant lymphoma.
Time frame: 90 days post infusion
Duration of Response after administration
Time frame: 90 days post infusion
Progress Free Survival after administration
Time frame: 90 days post infusion
Overall Survival after administration
Time frame: 90 days post infusion
The immunogenicity of Human CD19 targeted T Cells Injection. (HAMA detection of human anti-mouse antibody)
Time frame: 2 years post infusion
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