Results are attained without requiring lymphodepletion.

SHENZHEN, China, April 30, 2025 /PRNewswire/ -- Genocury Biotech today revealed groundbreaking clinical data from its noval in vivo CD19 CAR-T therapy in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), a notoriously aggressive blood cancer. In a investigator-initiated trial (IIT) led by the Hematology Department at Tongji Hospital, a heavily pretreated relapsed/refractory (R/R) patient with advanced DLBCL achieved complete remission (CR) after 1 month of the in vivo CAR-T treatment, with durable response sustained over three months. Notably, the treatment eliminated the need for lymphodepletion, a standard yet toxic preconditioning step in traditional CAR-T protocols.

Clinical Breakthrough: Redefining Safety, Efficacy, and Speed

Key trial findings:

1. Rapid and Deep Response:

A relapsed DLBCL male patient achieved complete hematological remission (CR) within 28 days following a single dose of Genocury's CD19 in vivo CAR-T without lymphodepletion. Flow cytometric analysis revealed significant CAR-T cell expansion kenetics, with sustained therapeutic efficacy confirmed through 90-day follow-up monitoring.

2. Unprecedented Safety Profile:

Unlike conventional CAR-T, which carries a ~50% risk of cytokine release syndrome (CRS) and neurotoxicity, this novel therapeutic approach demonstrated complete absence of: 

• Cytokine release syndrome (CRS)
• Immune effector cell-associated neurotoxicity syndrome (ICANS)
• Lymphodepletion-related complications - typically associated with increased infection risk- further underscores the therapy's safety profile.

Reimagining CAR-T: In Vivo Engineering Breakthroughs

Genocury's in vivo CAR-T platform overcomes two critical roadblocks in current CAR-T therapy:

• Eliminates Ex Vivo Manipulation: Traditional CAR-T requires 3-4 week vein-to-vein timeline by harvesting, modifying, and expanding a patient's T cells outside the body, and $400K price tag stem from this time-consuming process. Genocury's proprietary in vivo CAR-T vector delivers CAR payload directly into circulating T cells in vivo, enabling functional CAR-T generation.
• Lymphodepletion-Free Protocol: Current protocols require the harsh preconditioning chemotherapy for immune reset - a leading cause of hospitalization. Genocury's lymphodepletion-free approach reduces treatment-related complications and logistical burdens, as well as enabling significant CAR-T cell expansion.

Statement from Prof. Jia Wei , M.D., Ph.D.

PI (principal investigator), Tongji Hospital Cancer Center (Wuhan)
 "In this groundbreaking case, we observed the patient treated with Genocury's CD19 in vivo CAR-T achieved complete remission through 90-day follow-up - achieved without any lymphodepletion, which fundamentally challenges current cellular therapy dogma" said Dr. Jia Wei, "This therapy combines the benefits of autologous CAR-T with the accessibility of universal therapies, potentially ending the era of unaffordable cancer treatments. This could democratize access to CAR-T globally, we are very excited to advance this paradigm-shifting approach."

About Genocury Biotech
Shenzhen Genocury Biotech Co., Ltd. is a clinical-stage biotechnology pioneer redefining in vivo cell engineering through its proprietary Vivoexpress™ platform. This modular delivery system enables targeted delivery of genetic payloads with organ-specific tropism. The company dedicated to deliver next-generation immunotherapies for oncology and autoimmune disorders by developing universal cell and gene therapies for patients worldwide.

About Tongji Hospital Hematology Department
Since its establishment in 1959, the Hematology Department of Tongji Hospital is one of China's earliest and most prestigious hematology centers. Recognized for clinical excellence and innovative research, it evolved into a premier academic medical center well known as a national key discipline (2007) and national clinical key specialty (2011), and serves as the largest cell immunotherapy center in Hubei Province. With 74 medical professionals, including 22 full professors and 50 PhD practitioners, the department collectively manage over 10.000 annual patient cases. Specializing in complex hematologic malignancies ranging from leukemia, lymphoma, and myeloma to multiple other hematologic malignancies, Tongji Hospital Hematology Department solidifies its position as a leading clinical and research institution in Asia.

Media Contact: geno@genocury.com