Drug intelligence / Profile preview

GC007F

Development stage
Phase 1
Lead developer
Gracell Biotechnologies
Modality
CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Gene Therapies, Vaccines & Immunotherapeutics
Administration
Intravenous
01

Overview

GC007F is an autologous CD19-targeted chimeric antigen receptor T cell (CAR-T) therapy developed using Gracell Biotechnologies' proprietary FasT CAR technology. This investigational therapy involves genetically modifying a patient's own T lymphocytes to express a CAR specific for the CD19 antigen, which is commonly found on B cells. The manufacturing process for GC007F is notably rapid, producing functional CAR-T cells within 24 hours, compared to conventional methods that require several days. Preclinical and clinical studies have demonstrated that GC007F exhibits superior proliferation, persistence, and tumor-killing capacity compared to conventional CAR-T products. It has shown high rates of complete remission in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), including high rates of minimal residual disease negativity[1][3][6][8]. The most common adverse events include cytokine release syndrome and neurotoxicity.

Brand names
ARM011ARM-011ARM 011
Other names
FasT CAR-19
02

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