A Phase 1 interventional study of Human CD19 targeted T Cells Injection in CD19-positive, Diffuse Large B-cell Lymphoma and Follicular Lymphoma, sponsored by Hrain Biotechnology Co., Ltd.. Status unknown at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-08-31.
Sponsored by Hrain Biotechnology Co., Ltd. · Phase 1, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 18 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Hrain Biotechnology Co., Ltd. is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male or female subjects with CD19+ B cell lymphomas who have a limited prognosis (several months to \<2 year survival) with currently available therapies will be enrolled.
Pathology demonstrated that CD19-positive B-cell non-Hodgkin's lymphoma and who meet one of the following conditions:
Liver, kidney and cardiopulmonary functions meet the following requirements:
Exclusion Criteria:
Drug: Human CD19 targeted T Cells Injection
Autologous genetically modified anti-CD19 CAR transduced T cells
Safety 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
Plan to share: No
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Hrain Biotechnology Co., Ltd.