AbelZeta's C-CAR168 Receives EMA PRIME Designation for Refractory SLE and Lupus Nephritis
核心洞察
AbelZeta Pharma (搜索)'s dual-target CAR-T therapy C-CAR168 has received EMA PRIME designation for refractory systemic lupus erythematosus (搜索), with or without lupus nephritis (搜索).
C-CAR168 is a novel autologous bi-specific CAR-T targeting both CD20 (搜索) and BCMA (搜索), designed to deplete autoreactive B cells and antibody-producing plasma cells for deeper immune reset.
The PRIME designation follows a U.S. FDA RMAT designation granted in May 2025, marking significant regulatory recognition for CAR-T in autoimmune disease.
AbelZeta Pharma (搜索), Inc., a global clinical-stage biopharmaceutical company, announced on July 20, 2026 that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted PRIority MEdicines (PRIME) designation for C-CAR168, the company's novel autologous anti-CD20 (搜索)/BCMA (搜索) CAR-T product candidate, for the treatment of refractory Systemic Lupus Erythematosus (搜索) (SLE), with or without Lupus Nephritis (搜索) (LN).
The granting of EMA PRIME designation marks one of the first major regulatory recognitions of a CAR-T therapy for SLE, highlighting both the significant unmet need faced by lupus patients and the potential of this approach to transform treatment.
"A 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," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "It provides important momentum as we advance C-CAR168 through global development in multiple disease indications and further establishes AbelZeta as a leader in cell therapy for autoimmune diseases."
Dual-Target Rational Design
C-CAR168 is a novel autologous bi-specific CAR-T therapy engineered to target both CD20 (搜索) and BCMA (搜索) simultaneously. Building on the clinical promise demonstrated by earlier CAR-T therapies, AbelZeta has applied extensive expertise in developing dual-target CAR-T technology to create this next-generation construct. The therapy has been rationally designed to more effectively address the underlying immunopathology of lupus by targeting both autoreactive B cells and antibody-producing plasma cells, with the goal of achieving deeper, more durable remissions while maintaining a favorable safety profile.
The dual-targeting approach supports deep depletion of disease-driving B cells and plasma cells, aiming to induce an immune reset in patients with severe autoimmune diseases, including refractory SLE and LN, progressive Multiple Sclerosis (MS), and others.
Regulatory Momentum Across Jurisdictions
The EMA PRIME designation follows an earlier regulatory milestone: in May 2025, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to C-CAR168 for the same indication — refractory SLE, including LN. The PRIME scheme, established by the EMA, is granted to promising medicines that may address significant unmet medical needs and provides enhanced regulatory support, including early dialogue and scientific advice, to help optimize development and potentially accelerate evaluation.
Disease Burden and Unmet Need
SLE is a chronic autoimmune disease characterized by systemic inflammation and multi-organ involvement. LN represents a serious manifestation of SLE involving inflammation of the kidneys that can lead to progressive kidney damage and kidney failure. Despite available standards of care, patients with refractory disease continue to face significant unmet medical needs, including persistent disease activity, risk of organ damage, and cumulative toxicity associated with long-term immunosuppressive treatment.
AbelZeta, with centers of excellence in Rockville, Maryland and Shanghai, China, focuses on developing innovative and proprietary cell-based therapeutic products targeting hematological malignancies, inflammatory and immunological diseases, and solid tumors. The company advances research and development in its own GMP facilities, with a pipeline comprised of multiple CAR-T therapies.