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FL33 CAR-T cells
- Development stage
- Unknown
- Modality
- CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Gene Therapies
- Administration
- Intravenous
01
Overview
FL33 CAR-T cells (also referred to as FL-33 or optimized CD33 CAR-T cells) are an investigational chimeric antigen receptor (CAR) T-cell therapy targeting CD33, a transmembrane protein highly expressed on acute myeloid leukemia (AML) cells. The therapy has undergone several iterations to optimize its safety and efficacy profile. While the initial version (FL33-01) showed anti-leukemic activity, it was associated with severe cytokine release syndrome (CRS). Subsequent versions, FL33-02 and FL33-03, were developed to address these safety concerns. Notably, the FL33-03 variant is engineered to down-regulate TNFα production, which aims to reduce systemic inflammatory toxicity and improve the overall safety profile. The therapy is currently being evaluated in a Phase 1/2 clinical trial (NCT06326021) for the treatment of relapsed or refractory AML, exploring both autologous and donor-derived cell sources, often as a bridge to hematopoietic stem cell transplantation (HSCT).
- Other names
- optimized CD33 CAR-T cells
02
Targets
CD33 (Myeloid cell surface antigen CD33)
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