QT-019C – First Chinese Universal CAR-T for Autoimmune Disease with FDA Breakthrough Designation

QT-019C — a dual-targeting allogeneic CAR-T from Qihan Biotech — is the first Chinese-developed cell therapy to receive FDA RMAT and Breakthrough Therapy Designation for autoimmune disease, targeting refractory SLE and myasthenia gravis.

Introduction

Autoimmune diseases represent a major unmet medical need worldwide, affecting an estimated 50 million people in the United States alone. Patients with severe, refractory autoimmune diseases such as systemic lupus erythematosus (SLE) and myasthenia gravis (MG) often have limited treatment options and poor outcomes despite intensive immunosuppression.

In 2026, Qihan Biotech (启函生物) achieved a historic milestone: its universal CAR-T product, QT-019C, received FDA Regenerative Medicine Advanced Therapy (RMAT) designation and FDA Breakthrough Therapy Designation for the treatment of relapsed/refractory autoimmune diseases. This marks the first time a Chinese-developed cell therapy has received these designations for autoimmune disease.

The QT-019C Universal CAR-T Platform

QT-019C is an allogeneic (universal) dual-targeting CAR-T therapy designed to deplete B cells in patients with refractory autoimmune diseases.

Key features:

• Off-the-shelf availability — manufactured from healthy donor T cells, ready for immediate use
• Dual targeting — engineered to recognize and eliminate B cells through multiple surface markers
• Gene-edited safety — TCR and HLA disruption to prevent GVHD and immune rejection
• Low-intensity preconditioning — designed for use with reduced-intensity lymphodepletion

As Dr. Yang Luhua, founder of Qihan Biotech, commented: "We are excited to advance QT-019C into the clinic for patients with severe autoimmune diseases. This represents a paradigm shift from lifelong immunosuppression to durable, potentially curative therapy."

FDA Regulatory Milestones

QT-019C has achieved two of the most prestigious FDA designations for novel therapies:

1. Regenerative Medicine Advanced Therapy (RMAT) Designation

RMAT designation is granted to regenerative medicine therapies that demonstrate the potential to address unmet medical needs for serious or life-threatening diseases or conditions. RMAT designation provides:

• Increased interaction with FDA review teams
• Rolling review of biologics license applications
• Potential for priority review

2. Breakthrough Therapy Designation

Breakthrough Therapy Designation is reserved for therapies that demonstrate substantial improvement over existing therapies on clinically significant endpoints. It provides:

• Intensive FDA guidance throughout development
• Organizational commitment from FDA senior management
• Eligibility for rolling review and priority review

QT-019C is the first Chinese-developed cell therapy to receive Breakthrough Therapy Designation for an autoimmune disease, validating the quality and potential of China's cell therapy innovation.

Indications: SLE and Myasthenia Gravis

QT-019C is initially being developed for two severe autoimmune diseases:

Systemic Lupus Erythematosus (SLE)

SLE is a chronic autoimmune disease that affects multiple organ systems, including the skin, joints, kidneys, and nervous system. It primarily affects women of childbearing age and can be life-threatening, particularly when it involves the kidneys (lupus nephritis).

Myasthenia Gravis (MG)

MG is a neuromuscular autoimmune disorder characterized by fluctuating muscle weakness, including ptosis, diplopia, and respiratory muscle weakness. Severe MG can be life-threatening and is associated with significant morbidity.

Both diseases are driven by pathogenic B cells and autoantibodies, making B-cell depletion a rational therapeutic strategy.

Significance for International Patients

For international patients with refractory autoimmune diseases, QT-019C offers:

• Access to a breakthrough-designated therapy — one of the first CAR-T therapies for autoimmune disease
• Off-the-shelf availability — no waiting time for personalized manufacturing
• Potential for durable remission — unlike lifelong immunosuppression, CAR-T may provide long-term disease control