Drug intelligence / Profile preview

SYNCAR-001

Development stage
Phase 1
Lead developer
Synthekine
Modality
CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

SYNCAR-001 is an autologous CD19-targeting chimeric antigen receptor T cell (CAR-T) therapy that expresses an engineered interleukin-2 (IL-2) receptor, allowing it to selectively respond to STK-009, an engineered pegylated IL-2 cytokine. This two-component regimen—referred to as SYNCAR-001 + STK-009—is designed using Synthekine’s proprietary orthogonal IL-2 technology. The combination enables targeted activation and expansion of the CAR-T cells in vivo without the need for lymphodepleting chemotherapy. It is being developed primarily for autoimmune diseases such as systemic lupus erythematosus (SLE), lupus nephritis (LN), and also evaluated in B-cell malignancies including non-Hodgkin lymphoma and other CD19-positive hematologic cancers. Early clinical data show a favorable safety profile with durable responses in treated patients[1][3][4][5].

Other names
SYNCAR 001SYNCAR001SYNCAR-001
02

Targets

CD19 (B lymphocyte antigen CD19)orthoIL-2Rβ (Engineered orthogonal IL-2 receptor beta)

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