NCT03685786

CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT

The Study of Autologous T Cells Expressing CD19 Chimeric Antigen Receptors Treatment of Minimal Residual Disease(MRD) of B Cell Malignancies and Then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shenzhen Second People's Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT

Detailed description

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).

Conditions

• Leukemia, Lymphocytic, Acute, B-Cell
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma, B-Cell

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-01
• Primary completion: 2021-06-02
• Completion: 2021-09-02
• First posted: 2018-09-26
• Last updated: 2018-12-07

Locations

1 site across 1 country: China