A Phase 1 interventional study of CART19 cell and auto-HSCT in Leukemia, Lymphocytic, Acute, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, B-Cell, sponsored by Shenzhen Second People's Hospital. Status unknown at 1 site in China. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-12-07.
Sponsored by Shenzhen Second People's Hospital · Phase 1, Interventional, and Treatment
The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT
The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 20 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Shenzhen Second People's Hospital is the lead sponsor of 48 studies on the registry; 8 are open to participants now.
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CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.
Biological: CART19 cell and auto-HSCT
Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10\^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10\^7 CART19 cells, Day 1, 30% fraction: 1.5x10\^7-1.2x10\^8 CART19 cells, Day 2, 60% fraction: 3x10\^7-2.4x10\^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
The incidence of conversion of minimal residual disease (MRD) to \<0.01% after CART19 therapy in patients with MRD of B Cell Malignancies during upfront treatment
Time frame: day 28
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Shenzhen Second People's Hospital