NCT02933775

CD19-redirected Autologous Cells (CAR-CD19 T Cells)

Autologous T Cells With a Chimeric Antigen Receptor in Patients With CD19-positive Malignant B Cell Leukemia and Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed for determining the safety and relative engraftment levels of the redirected autologous T cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell leukemia and malignant lymphoma.

Detailed description

A single arm open-label pilot study is designed to determine the safety, tolerability and engraftment potential of CAR-CD19 T cells in patients with CD19-positive malignant B cell leukemia and lymphoma. All subjects will receive CAR-CD19 T cells infusion. Primary objectives: 1. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD19 lentiviral vector (referred to as "CAR-CD19 T" cells). 2. Determine the duration of in vivo survival of CAR-CD19 T cells. Secondary objectives: 1. For patients with detectable disease, measure anti-tumor response due to CAR-CD19 T cells infusions. 2. To determine the amplification and survival of CAR-CD19 T 4-1BB:CD3ζ and CD28:CD3ζ as measured by the relative engraftment levels of CAR-CD19 T 4-1BB:CD3ζ and CD28:CD3ζ cells over time. 3. Estimate relative trafficking of CAR-CD19 T cells to tumors in bone marrow and lymphnodes. 4. Determine if cellular or humoral host immunity develops against the murine anti-CD19, and assess correlation with loss of detectable CAR-CD19 T (loss of engraftment). 5. Determine the relative subsets of CAR-CD19 T cells.

Conditions

• CD19 Positive Malignant B-cell Leukemia and Lymphoma

Interventions

Type	Name	Description
GENETIC	CAR-CD19 T cells	Initial dose: A total of 1 - 10×10\^7 CAR-CD19 T cells/kg will be administered by 1 - 3 infusions. Subsequent dose will be based on the subject's response to initial dose.
DRUG	Fludarabine	30 mg/m\^2/day×4 days
DRUG	Cyclophosphamide	500 mg/m\^2/day×2 days

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-04-01
• Completion: 2020-01-01
• First posted: 2016-10-14
• Last updated: 2016-10-14

Locations

1 site across 1 country: China