- Program
- CD22 CAR T
- Indications
- CD19 R/R, LBCL
- Phase
- 90% of Phase 1
*Phase 3 may not be required if the preceding phase is registrational.
B-cells are an important part of the human immune system that make antibodies to fight infections. Lymphoma originating from B cells are called B-cell lymphomas. Large B-cell lymphoma (LBCL) is the most common aggressive lymphoid malignancy in the United States and Europe, accounting for approximately 30 to 40% of all non-Hodgkin lymphomas (NHL). Many patients (30-50%) do not respond to, or relapse after, their first treatment, and then become eligible for chimeric antigen receptor (CAR) T-cell therapy targeting CD19. CD19 CAR T-cell therapies can induce long-term remission in some patients, however, the majority of patients experience disease progression within a year, primarily due to diminished or absent surface CD19 expression. There are currently no approved treatments for patients with R/R LBCL who do not respond to or relapse following treatment with CD19 CAR T-cell therapies.
Sixty percent of LBCL patients treated with CD19 CAR T-cell therapies do not experience durable responses due to resistance, and many patients lack access to these potentially curative therapies. For patients with LBCL that have relapsed or are refractory (R/R) to CD19 CAR T-cell therapies, outcomes are poor. Targeting of alternative antigens represents an important therapeutic strategy for patients who relapse after CD19 CAR T-cell therapies, including those with CD19 loss or downregulation.
CD22 is expressed on the majority of B-cell lymphomas. CD22 CAR T-cell therapy is a novel therapeutic option for patients with R/R LBCL after CD19 CAR T-cell therapy. CRG-022 is CARGO’s investigational cell therapy that is composed of autologous T-cells transduced with a lentiviral vector expressing a CD22-targeting CAR (m971-BBZ).
CRG-022 is currently being evaluated in a Phase 1/1b clinical trial (NCT04088890) of autologous CD22 CAR T-cells in patients with LBCL that is R/R to CD19 CAR T-cell therapy. Initial results in adults demonstrate the safety and antitumor activity of CAR T-cell therapy targeting CD22 in patients with LBCL that is R/R to CD19 CAR T-cell therapy. CARGO believes that CRG-022 has the potential to treat LBCL in patients for whom prior CD19 CAR T-cell therapies have failed.
CARGO is also advancing its proprietary platform technologies and discovery-stage programs targeting other hematologic malignancies and solid tumors.