Drug intelligence / Profile preview

soficabtagene geleucel

Development stage
Phase 2
Lead developer
Wugen
Modality
CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

**Soficabtagene geleucel (WU-CART-007)** is an allogeneic, off-the-shelf CAR-T cell therapy developed by Wugen, Inc., targeting **CD7** on malignant T-cells. It utilizes CRISPR-edited healthy donor T-cells engineered to be fratricide-resistant, enabling robust expansion and persistence despite high CD7 expression on normal T-cells. Administered as a single infusion following lymphodepleting chemotherapy, it has shown promising efficacy in heavily pretreated patients with relapsed/refractory T-cell malignancies, achieving an **81.8% composite complete remission rate** at the recommended phase 2 dose (900 million cells) in a phase 1/2 trial for T-ALL/LBL, with manageable safety including cytokine release syndrome (CRS, 88.5%; 19.2% grade 3-4) and low rates of neurotoxicity or GVHD[1][5][9].

Brand names
Sofi-cel
Other names
Anti-CD7 Allogeneic CAR-T Cells (Wugen)
02

Targets

CD7 (CD7 antigen)

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