EMA’s CHMP grants PRIME status to AbelZeta’s C-CAR168

An autologous anti-cluster of differentiation 20/B-cell maturation antigen (CD20/BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, C-CAR168 aims to treat refractory systemic lupus erythematosus (SLE), with or without lupus nephritis (LN).

SLE is a chronic autoimmune condition distinguished by systemic inflammation and effects on multiple organs while LN is a serious kidney complication in SLE, which can result in progressive kidney damage.

This PRIME designation is designed to provide additional regulatory support and guidance for medicines that may address significant unmet medical needs.

Under this programme, designated therapies are eligible for early dialogue and scientific advice from regulators, with the intention of optimising their development and potentially accelerating their evaluation process.

C-CAR168 is aimed at depleting both autoreactive B cells and antibody-producing plasma cells, with the goal of inducing immune reset in patients with severe autoimmune disorders such as refractory SLE and LN.

This approach is intended to achieve deeper and longer-lasting remissions while aiming to maintain a favourable safety profile.

AbelZeta chairman and CEO Tony (Bizuo) Liu said: “The PRIME designation represents another significant milestone for AbelZeta’s scientific capabilities and further demonstrates that well-designed early clinical trials can generate highly clinically meaningful results that translate into regulatory recognition and inform global drug development.

“This recognition reflects the strength of our scientific platform, the dedication of our team, and the significant progress we have made in expanding cell therapy well beyond oncology.”

In May 2025, the US Food and Drug Administration (FDA) granted C-CAR168 regenerative medicine advanced therapy (RMAT) designation for the treatment of refractory SLE, including LN.

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