Genocury Biotech Unveils Breakthrough in Relapsed/Refractory DLBCL with Innovative In Vivo CD19 CAR-T Therapy

Genocury Biotech, a company based in Shenzhen, China, has announced significant clinical trial results involving its innovative in vivo CD19 CAR-T therapy. This treatment has shown promising results for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), a particularly aggressive form of blood cancer. The trial was conducted by the Hematology Department at Tongji Hospital, where a patient with advanced DLBCL achieved complete remission within one month of receiving the treatment. This remission was maintained for at least three months, marking a notable milestone in cancer therapy.

The therapy's most groundbreaking aspect is its elimination of the necessity for lymphodepletion, a common preconditioning step in traditional CAR-T therapies that is often associated with significant toxicity. This development could potentially transform current CAR-T treatment protocols, which typically involve several weeks of cell manipulation outside the body and can be costly and time-consuming.

In this trial, a male patient with relapsed DLBCL experienced complete hematological remission 28 days after a single dose of Genocury's in vivo CD19 CAR-T therapy. The treatment's efficacy was further demonstrated by a 90-day follow-up, showing sustained therapeutic effects through flow cytometric analysis, which revealed significant CAR-T cell expansion.

The safety profile of this new therapy is also noteworthy. Traditional CAR-T therapies carry a high risk of cytokine release syndrome (CRS) and neurotoxicity, but Genocury's in vivo CD19 CAR-T treatment showed no signs of these adverse effects. The absence of lymphodepletion-related complications was particularly significant, as this preconditioning step is known to increase infection risks.

Genocury's approach to in vivo CAR-T therapy addresses major challenges in current CAR-T treatments. It removes the need for ex vivo manipulation, where T cells are typically harvested, modified, and expanded outside the body. This traditional method often involves a lengthy timeline and high costs, with treatments reaching up to $400,000. Instead, Genocury's proprietary vector delivers the CAR payload directly into circulating T cells within the body, facilitating quicker and more cost-effective therapy.

Furthermore, eliminating the need for lymphodepletion reduces treatment-related complications and logistical burdens, while enabling significant CAR-T cell expansion. This advances the field of CAR-T therapy by offering a potentially safer and more accessible treatment option.

Dr. Jia Wei, the principal investigator at Tongji Hospital Cancer Center, commented on the trial's success, noting the patient achieved complete remission without any lymphodepletion. This result challenges existing cellular therapy norms and combines the advantages of autologous CAR-T with the accessibility of universal therapies. Dr. Wei expressed hopes that this innovation could make CAR-T therapy more affordable and accessible worldwide, potentially democratizing cancer treatment.

Genocury Biotech, through its Vivoexpress™ platform, is a leader in in vivo cell engineering. The company focuses on developing next-generation immunotherapies for oncology and autoimmune disorders, using targeted delivery systems for genetic payloads. This commitment to advancing cell and gene therapies underscores Genocury's role in pioneering innovative treatments for patients globally.

The Hematology Department at Tongji Hospital, established in 1959, is one of China's foremost centers for hematology. Known for its clinical excellence and research innovation, it has become a leading academic medical institution in Asia. With a large team of professionals, the department manages numerous complex hematologic malignancies each year, reinforcing its status as a key player in the field.