Phase 1 Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults with Recurrent or Refractory B Cell Malignancies
Grant Award Details
Grant Type:
Grant Number:
CLIN2-10846
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Cell Line Generation:
Award Value:
$11,034,982
Status:
Closed
Progress Reports
Reporting Period:
Operational Milestone #5
Grant Application Details
Application Title:
Phase 1 Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults with Recurrent or Refractory B Cell Malignancies
Public Abstract:
Therapeutic Candidate or Device
T cells genetically engineered to express as bispecific Chimeric Antigen Receptor (CAR) targeting CD19 and/or CD22
Indication
Patients with relapsed and refractory B cell malignancies
Therapeutic Mechanism
T cells expressing the bispecific CAR will recognize cancer cells expressing one of both of the target antigens. Upon recognition, the T cells will become activated, divide, and then kill the cancer cells. Progenitor T cells contained within the larger population will form memory stem cells that will persist and continue to survey the body and kill residual cancer. These cancer killing T cells are designed to persist for years following one treatment with CD19/22-CAR T cells.
Unmet Medical Need
50% or less of patients with diffuse large B cell lymphoma and B cell leukemia are cured with standard regimens, that rely on chemotherapy for benefit. CD19/22-CAR T cells effectively kill chemotherapy resistant lymphoma and leukemia and thus could improve cure rates for these aggressive cancers.
Project Objective
Phase 1 trial completed
Major Proposed Activities
T cells genetically engineered to express as bispecific Chimeric Antigen Receptor (CAR) targeting CD19 and/or CD22
Indication
Patients with relapsed and refractory B cell malignancies
Therapeutic Mechanism
T cells expressing the bispecific CAR will recognize cancer cells expressing one of both of the target antigens. Upon recognition, the T cells will become activated, divide, and then kill the cancer cells. Progenitor T cells contained within the larger population will form memory stem cells that will persist and continue to survey the body and kill residual cancer. These cancer killing T cells are designed to persist for years following one treatment with CD19/22-CAR T cells.
Unmet Medical Need
50% or less of patients with diffuse large B cell lymphoma and B cell leukemia are cured with standard regimens, that rely on chemotherapy for benefit. CD19/22-CAR T cells effectively kill chemotherapy resistant lymphoma and leukemia and thus could improve cure rates for these aggressive cancers.
Project Objective
Phase 1 trial completed
Major Proposed Activities
- Demonstrate feasibility of producing CD19/22-CAR T cells
- Assess toxicity of CD19/22-CAR T cells
- Assess clinical activity of CD19/22-CAR T cells in adults with B-ALL and DLBCL.
Statement of Benefit to California:
In California, approximately 2000 adults are diagnosed annually with DLBCL and 600 with B-ALL.. At least one third will not respond to chemotherapy based treatment and most will die of their disease within one year. The CD19/22-CAR provides a new, potentially effective therapy for these patients.. It could demonstrate both a higher response rate and greater long-term effectiveness than the CD19-CAR that has recently received FDA approval for these patients.