Genocury has initiated clinical trials for its in vivo CD19 CAR-T therapy, showcasing promising safety, effectiveness, and lasting impact.

These outcomes were achieved without the need for lymphodepletion.

SHENZHEN, China, April 30, 2025 — Genocury Biotech today announced significant clinical data concerning its innovative in vivo CD19 CAR-T therapy for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), a particularly virulent form of blood cancer. An investigator-initiated trial (IIT) conducted by the Hematology Department at Tongji Hospital revealed that a heavily pretreated patient with advanced relapsed/refractory (R/R) DLBCL achieved complete remission (CR) one month after receiving the in vivo CAR-T treatment, with the positive response persisting for over three months. Importantly, the treatment did not require lymphodepletion, a common but potentially harmful preconditioning step in standard CAR-T procedures.

Clinical Breakthrough: Redefining Safety, Efficacy, and Speed

Key trial findings:

1. Rapid and Deep Response:

A male patient with relapsed DLBCL achieved complete hematological remission (CR) within 28 days of receiving a single dose of Genocury’s CD19 in vivo CAR-T without lymphodepletion. Flow cytometry showed significant CAR-T cell expansion, and the therapeutic efficacy was maintained throughout the 90-day follow-up.

2. Unprecedented Safety Profile:

In contrast to conventional CAR-T, which carries an approximate 50% risk of cytokine release syndrome (CRS) and neurotoxicity, this new therapeutic approach demonstrated a complete absence of:

• Cytokine release syndrome (CRS)
• Immune effector cell-associated neurotoxicity syndrome (ICANS)
• Complications related to lymphodepletion – typically associated with a higher risk of infection – further highlights the therapy’s safety profile.

Reimagining CAR-T: In Vivo Engineering Breakthroughs

Genocury’s in vivo CAR-T platform addresses two major challenges associated with current CAR-T therapy:

• Eliminates Ex Vivo Manipulation: Traditional CAR-T necessitates a 3-4 week vein-to-vein period for harvesting, modifying, and expanding a patient’s T cells outside the body, and the process contributes to a $400K price tag. Genocury’s proprietary in vivo CAR-T vector directly delivers the CAR payload into circulating T cells in vivo, resulting in functional CAR-T cell generation.
• Lymphodepletion-Free Protocol: Existing protocols require harsh preconditioning chemotherapy for immune reset, a primary cause of hospitalization. Genocury’s lymphodepletion-free method lowers treatment-related complications and logistical challenges, while also promoting significant CAR-T cell expansion.

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

PI (principal investigator), Tongji Hospital Cancer Center (Wuhan)
 “In this remarkable case, we observed that the patient treated with Genocury’s CD19 in vivo CAR-T achieved complete remission, which was maintained throughout the 90-day follow-up. This was without any lymphodepletion, which significantly deviates from current cellular therapy standards,” said Dr. Jia Wei. “This therapy combines the advantages of autologous CAR-T with the convenience of universal therapies, potentially marking the end of unaffordable cancer treatments. This could broaden access to CAR-T on a global scale, and we are very enthusiastic about advancing this game-changing approach.”

About Genocury Biotech
Shenzhen Genocury Biotech Co., Ltd. is a clinical-stage biotechnology company that is pioneering in vivo cell engineering through its Vivoexpress platform. This adaptable delivery system facilitates targeted delivery of genetic payloads with specific organ tropism. The company is committed to providing next-generation immunotherapies for oncology and autoimmune disorders by creating universal cell and gene therapies for patients globally.

About Tongji Hospital Hematology Department
Since its founding in 1959, the Hematology Department of Tongji Hospital has been one of China’s earliest and most respected hematology centers. Known for its clinical excellence and innovative research, it has developed into a leading academic medical center, recognized as a national key discipline (2007) and national clinical key specialty (2011), and serves as the largest cell immunotherapy center in Hubei Province. With a team of 74 medical professionals, including 22 full professors and 50 PhD practitioners, the department collectively manages over 10,000 patient cases annually. Specializing in complex hematologic malignancies, including leukemia, lymphoma, myeloma, and other related conditions, the Tongji Hospital Hematology Department has solidified its position as a premier clinical and research institution in Asia.

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SOURCE Genocury Biotech

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