NCT03559439

CD19-targeting CAR T Cells in Relapsed or Refractory CD19 Positive B-cell Malignancies

CD19-targeting CAR T Cell Therapy in the Treatment of Relapsed or Refractory CD19 Positive B-cell Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Shanghai Tong Ren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm, open-label phase 1 study to determine the safety and efficacy of autologous T cells expressing CD19 chimeric antigen receptors in adults with CD19+ B cell malignancies.

Detailed description

This is a single-center, Open Label phase I clinical trial, 9 subjects planned to be enrolled. The subjects will be divided into low-dose group, medium-dose group and high-dose group.Dose CAR+ cells/kg Low 1×105 Medium 2×106 High 6×106

Conditions

• B-cell Malignancy
• B-cell Lymphoma
• B-Cell Acute Lymphoblastic Leukaemia

Interventions

Type	Name	Description
BIOLOGICAL	CD19 CAR T	CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv CD3z:CD28 administered by IV infusion. Subjects will receive 0.1-10 x 10\^6 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction, Day 2, 30% fraction, Day 3, 60% fraction.

Timeline

• Start date: 2018-04-24
• Primary completion: 2021-11-30
• Completion: 2021-12-31
• First posted: 2018-06-18
• Last updated: 2020-11-05

Locations

1 site across 1 country: China