Genocury Pioneers Lymphodepletion-Free In Vivo CAR-T with Positive Clinical Data

SHENZHEN, China, April 30, 2025 /PRNewswire/ — Today, Genocury Biotech unveiled encouraging clinical data concerning its innovative in vivo CD19 CAR-T therapy for patients battling relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), a particularly aggressive form of blood cancer. In an investigator-sponsored study managed by the Hematology Department at Tongji Hospital, a patient with heavily pretreated and relapsed/refractory advanced DLBCL experienced complete disappearance of cancer (CR) within a month following the in vivo CAR-T treatment. This positive response has persisted for over three months. A key aspect of this therapy is that it did not necessitate lymphodepletion, a common but toxic preparatory step in standard CAR-T procedures.

A Clinical Advancement: New Standards in Safety, Efficacy, and Speed

Key findings from the trial:

1. Rapid and Profound Response: A male patient with relapsed DLBCL achieved complete remission of blood-related cancer (CR) within 28 days after a single administration of Genocury’s CD19 in vivo CAR-T, and crucially, without undergoing lymphodepletion. Analysis using flow cytometry showed significant growth of CAR-T cells, and the therapy’s sustained effectiveness was confirmed through 90 days of follow-up observation.

2. Exceptional Safety Profile: In contrast to conventional CAR-T treatments, which carry an approximate 50% chance of cytokine release syndrome (CRS) and neurotoxicity, this novel therapeutic strategy showed a complete absence of:

   • Cytokine release syndrome (CRS)
   • Immune effector cell-associated neurotoxicity syndrome (ICANS)
   • Complications linked to lymphodepletion, which often include a higher risk of infections. This further emphasizes the therapy’s strong safety characteristics.

A New Vision for CAR-T: Breakthroughs in In Vivo Engineering

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

• No Need for External Cell Manipulation: Traditional CAR-T therapy has a 3-4 week timeframe from patient to patient, involving the removal, modification, and expansion of a patient’s T cells outside the body, which contributes to its $400,000 cost. Genocury’s unique in vivo CAR-T vector directly introduces the CAR genetic material into circulating T cells within the patient, enabling the generation of functional CAR-T cells inside the body.

• Protocol Without Lymphodepletion: Existing CAR-T protocols require intense pre-treatment chemotherapy to reset the immune system, a major cause of hospitalization. Genocury’s approach, which does not use lymphodepletion, lowers the risk of treatment-related issues and simplifies the logistical process, while also promoting significant CAR-T cell proliferation.

Commentary from Prof. Jia Wei, M.D., Ph.D. Principal Investigator, Hematology Department, Tongji Hospital (Wuhan)

“In this remarkable case, we observed a patient who received Genocury’s CD19 in vivo CAR-T achieve complete remission that has lasted for 90 days – and this was accomplished without any lymphodepletion, which fundamentally questions the established principles of cellular therapy,” commented Dr. Jia Wei. “This therapeutic approach combines the advantages of a patient’s own CAR-T cells with the accessibility of off-the-shelf therapies, potentially signaling the end of prohibitively expensive cancer treatments. This could broaden access to CAR-T therapy worldwide, and we are very enthusiastic about advancing this potentially transformative strategy.”