A phase 1/2 study to evaluate a bispecific CD19/CD20-directed CAR T cell, in refractory lupus nephritis and systemic lupus erythematosus
Grant Award Details
Grant Type:
Grant Number:
CLIN2-16063
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$8,000,000
Status:
Active
Grant Application Details
Application Title:
A phase 1/2 study to evaluate a bispecific CD19/CD20-directed CAR T cell, in refractory lupus nephritis and systemic lupus erythematosus
Public Abstract:
Therapeutic Candidate or Device
IMPT-514 is an autologous T-cell product genetically modified to express a chimeric antigen receptor targeting CD19 and CD20
Indication
Active, refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE)
Therapeutic Mechanism
Targeted depletion of pathogenic autoantibody-secreting B cells as well as CD20+ T cells by a bispecific CD19/CD20 -directed CAR T cell.
Unmet Medical Need
SLE is a chronic autoimmune disorder that can affect multiple organs, including the kidney (LN). A critical unmet need exists for well-tolerated therapies that offer efficacy with durable disease remission.
Project Objective
Phase 1 trial completed; Phase 2 trial underway
Major Proposed Activities
IMPT-514 is an autologous T-cell product genetically modified to express a chimeric antigen receptor targeting CD19 and CD20
Indication
Active, refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE)
Therapeutic Mechanism
Targeted depletion of pathogenic autoantibody-secreting B cells as well as CD20+ T cells by a bispecific CD19/CD20 -directed CAR T cell.
Unmet Medical Need
SLE is a chronic autoimmune disorder that can affect multiple organs, including the kidney (LN). A critical unmet need exists for well-tolerated therapies that offer efficacy with durable disease remission.
Project Objective
Phase 1 trial completed; Phase 2 trial underway
Major Proposed Activities
- Manufacture of IMPT-514 for participants with lupus nephritis and systemic lupus erythematosus participating in the Phase 1/2 trial of IMPT-514
- Enrollment of up to 12 patients in a Phase 1 clinical trial to demonstrate safety of IMPT-514 in patients with active and refractory lupus nephritis
- Enrollment of additional patients to evaluate the efficacy of IMPT-514 in participants with lupus nephritis or systemic lupus erythematosus
Statement of Benefit to California:
This innovative research study will advance a differentiated CAR T product, rooted in research at UCLA, with key contributions in recruitment from at least 2 major California centers (UCLA and UCSF). The potentially transformative therapy that IMPT-514 represents could improve the lives of patients with Systemic Lupus Erythematosus and Lupus Nephritis. As such, the transformative potential of this therapy could significantly relieve such healthcare burden in the State of California and beyond.