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Recently,Zhejiang Ruishun Biotech Co., Ltd. AnnouncesIts globally innovative R&DOff-the-shelf universal immune cell therapy product RJMty19 injection (main active ingredient is CD19-CAR-DNT cells)Positive clinical trial results achieved in an investigator-initiated clinical study (IIT) conducted by the Department of Hematology at the Second Affiliated Hospital of Zhejiang University School of Medicine.(Clinical Trial Number: NCT05453669), treating patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL).
As of August 25, 12 patients have completed DLT evaluation (dose-limiting toxicity), with no observed instances of ≥Grade 3 cytokine release syndrome (CRS), graft-versus-host disease (GvHD), immune effector cell-associated neurotoxicity syndrome (ICANS), or serious adverse events (SAE), demonstrating good clinical safety. In terms of clinical efficacy, a significant improvement has been observed with increasing doses.
All three subjects in the 4th dose group achieved clinical remission after a single dose.Objective Response Rate (ORR) was 100% (3/3)，Complete Response Rate (CRR)For33.3%（1/3）。
These preliminary data indicate that RJMty19 injection has promising clinical efficacy for patients with relapsed/refractory B-cell non-Hodgkin lymphoma.RJMty19 Injection, developed by Zhejiang Ruishun Biotech Co., Ltd. based on a global patent for humanized CD19-CAR, is an innovative, off-the-shelf, universal DNT cell therapy product. Compared with the six currently marketed CD19-CAR-T cell therapy products, CD19-CAR-DNT cells offer numerous advantages such as standardized production, low manufacturing costs, immediate availability for patients, and strong accessibility. It holds immense potential in the future market and can overcome the commercialization bottlenecks faced by current autologous CAR-T cell products.About Zhejiang Ruishun Biotech Co., Ltd.Zhejiang Ruishun Biotech Co., Ltd. focuses on the development of off-the-shelf universal immune cell products based on the DNT cell technology platform. It has currently developed multiple off-the-shelf universal cell therapy products using the DNT cell technology platform, including RC1012 Injection and RJMty19 Injection, among others. Two registered IND clinical trials and two investigator-initiated clinical trials for hematological tumors are currently underway.
