From Oncology to Autoimmunity: Bonal Bio's UCAR-T Achieves Dual-Track Breakthrough with IND Approval for BRL-303 in rSLE

Systemic Lupus Erythematosus（SLE）It is a systemic autoimmune disease characterized by abnormal B-cell activation and the production of autoantibodies, with traditional immunosuppressants showing limited efficacy in some patients. Although early IIT studies have indicated preliminary effectiveness of autologous CAR-T therapy for systemic lupus erythematosus, challenges such as long individualized preparation time and high costs remain. Therefore, allogeneic CAR-T cells, with advantages like homogeneity and immediate availability, have become a highly promising alternative solution.

BRL-303 is based on BRL Medicine's proprietary universal cell platform.（TyUCell^®）A brand-new generation of allogeneic universal CAR-T product targeting CD19, developed for the indication field of autoimmune diseases. This UCAR-T technology was researched and developed by a scientist team led by Professor Mingyao Liu and Professor Bing Du, founder & chairman of BRL Medicine, after 8 years of scientific research efforts and multiple technical iterations.It mainly achieves immune escape and functional optimization of allogeneic T cells through multiple gene editing technologies, which not only avoids the risks of graft-versus-host disease (GVHD) and host versus graft (HVG) from the source, but also precisely targets and regulates abnormally activated immune cells in SLE patients, rebuilding immune balance. This perfectly overcomes the core technical barriers of allogeneic CAR-T in the treatment of autoimmune diseases, marking another innovative transformation of universal cell therapy technology in the autoimmune field.Previously, BRL Medicine's BRL-303 UCAR-T treatment for SLE demonstrated significant clinical efficacy in two IIT clinical studies, with related research findings published in renowned international journals in 2025.Cell ResearchandMed。 

It is worth mentioning that the research results of this product in treating 3 patients with refractory autoimmune diseases were published in a top journal in July 2024.Cell, becoming the world's first reported clinical investigational product using allogeneic universal CAR-T to successfully treat autoimmune diseases.This research achievement has successively been awarded the important honors of "Top 10 Scientific and Technological Progress News in China in 2024, Selected by the Two Academies of Sciences and Engineering," "Top 10 Advances in China's Pharmaceutical and Biotechnology in 2024," and "Top 10 Scientific Advances in China in 2024," and has also received..."Father of CAR-T" Professor Carl JuneCell Publication Highly Comments: "Expected to Rewrite the Treatment Landscape of Autoimmune Diseases"It can be said that the existing clinical research has fully validated the application potential of BRL Medicine's allogeneic UCAR-T in the treatment of multiple indications, including tumors and autoimmune diseases.Showcased Three Core Advantages： 

As an "off-the-shelf" universal CAR-T product, this allogeneic UCAR-T does not require the collection of patient autologous cells or customized production. A single batch can meet the treatment needs of more than 200 cases, significantly reducing production costs. Meanwhile, its HLA-matching-free feature enables "ready-to-use" treatment, considerably shortening the waiting period for patients. It is especially suitable for cancer patients with rapidly progressing conditions and dysfunctional autologous immune cells, as well as refractory autoimmune patients, offering a convenient and accessible new treatment option for a broader patient population.

Unlike traditional treatment regimens with strong immunosuppression, this product does not require additional lymphodepletion or immunosuppression for patients. It can achieve complete clearance of target cells using only standard or even lower lymphodepletion protocols while effectively avoiding risks such as infection, agranulocytosis, and slow lymphocyte recovery caused by excessive immunosuppression. Previous clinical trial data showed that no patients treated with this product experienced cytokine release syndrome of grade ≥3.（CRS）Or Neurotoxicity（ICANS）, the infection rate is lower than that of similar products, demonstrating its excellent clinical safety.

This product, by selecting healthy donor T cells and optimizing the expansion process, exhibits stronger proliferation ability and long-term persistence in patients. In earlier clinical studies, the product has demonstrated the ability to precisely eliminate or suppress pathogenic cells in SLE patients while promoting the restoration of immune homeostasis, achieving long-term disease control and offering patients the possibility of avoiding recurring symptoms and achieving high-quality survival.

It must be said that the approval of BRL-303's IND in China not only opens up a brand-new treatment pathway for patients with moderate to severe refractory SLE, but also marks that BRL Medicine’s universal cell therapy technology has formed a dual-track layout of "hematological tumors + autoimmune diseases," which will help China’s innovative cell therapy technology continue to lead internationally. In the future, BRL Medicine will rapidly advance the multi-center clinical trials of BRL-303 UCAR-T in China and actively explore the application of UCAR-T technology in hematological tumors, solid tumors, and autoimmune diseases to benefit a wide range of patients.

References:

1. https://mp.weixin.qq.com/s/p1qUj_EVFegGLErfb-XhBA

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