Over One Year of Sustained Complete Metabolic Response Achieved with RayzeBio’s First-in-Class Off-the-Shelf CD19-CAR-DNT Cell Therapy for Non-Hodgkin Lymphoma
Wyze Biotech
Innovative Immune Cell Therapy Developer
August 14, 2025
eMedClub News
RJMty19 InjectionIt is a product developed by Zhejiang Ruishun Biotech Co., Ltd. based on the global patent of humanized CD19-CAR."Off-the-Shelf Universal" Second-Generation DNT Cell Therapy Product。
The main active ingredient of this product is DNT cells. DNT cells are a special subset of T cells present in human peripheral blood, accounting for 1%-10% of total T cells. They express CD3 but do not express CD4, CD8, or CD56 molecules. DNT cells highly express cell surface receptors such as NKG2D and DNAM-1, specifically recognizing target cells expressing corresponding ligands in an MHC non-restricted manner. They achieve the killing of tumor cells by secreting various cytotoxic molecules and cytokines, butDoes not cause graft-versus-host disease（GvHD）Host Anti-Graft Reaction（HvGR）。
It is worth mentioning that Zhejiang Ruishun Biotech Co., Ltd. has obtained the patent for the in vitro expansion of DNT cells at the research level from the University of Toronto, Canada.(2013)On the basis of, independently developedWorld's First Animal Serum-Free, Large-Scale In Vitro Expansion Clinical-GradeCore Technology of Human Peripheral Blood DNT Cells(2017)Currently, the cryopreservation process products have been used in clinical treatment for patients.
Compared with traditional autologous CAR-T therapy, RJMty19 injection, developed based on the DNT cell technology platform, has multiple advantages, including off-the-shelf availability, standardized and scalable production, multi-tumor killing ability, good safety, and significant efficacy.
Currently, a Phase 1 clinical trial of RJMty19 injection for the treatment of B-cell non-Hodgkin lymphoma is registered.（CTR20241469）Ongoing. The trial is led by Professor Zhao Weili's team from Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, with participation from Professor Hu Kai's team at Beijing Gaobo Hospital and Professor Li Yuhua's team from Zhujiang Hospital, Southern Medical University. To date, the trial has...11 casesThe subject completed DLT.(Dose-Limiting Toxicity)Evaluation.
According to the latest clinical data disclosed in the official press release, PET-CT results on Day 28 showed thatObjective Response Rate（ORR）For 71.4%, Complete Remission Rate（CRR）The ORR was 28.6%, with the longest duration of response being 9.79 months, of which, alreadyORR Reached 100% in 3 Subjects Receiving Multiple Doses, CRR reached 67%, indicating currentlyMultiple infusion clinical protocols can significantly improve their overall effectiveness.。
Ms. Wang, 34, is the second patient to receive Zhejiang Ruishun Biotech Co., Ltd's CD19-CAR-DNT cell therapy. She was diagnosed with non-GCB type double-expressor DLBCL in 2019 and achieved complete remission after six cycles of R-CHOP chemotherapy.（CR）. After the recurrence in 2024, the pathological type transformed into the GCB subtype, and nodules appeared on the left limb.
Less than 20 days after the failed attempt of oral BTK inhibitor trial, Ms. Wang joined the RJMty19 Injection registration clinical trial. Hospital admission evaluation showed an extremely high tumor burden, with multiple fused giant masses of approximately 30.9 cm x 15.6 cm on her left hip and thigh. PET-CT revealed abnormally active FDG metabolism.(SUVmax as high as 43.8)。
To maximize the cell therapy effect, the clinical team customized a plan specifically for Ms. Wang.RCHOP-like Bridging Regimen, aiming to effectively control tumor burden and optimize the immune microenvironment before a single infusion treatment with CD19-CAR-DNT cells. During the treatment, Ms. Wang only experienced mild adverse reactions such as low fever and anemia, with overall good tolerance.
Continuous PET-CT evaluations at 1 month, 3 months, 6 months, and 12 months post-infusion showed that Ms. Wang achieved sustained complete metabolic remission.（CMR）. This not only means that the tumor in her body has been effectively removed, but also indicates her long-term survival rate.（OS）Significantly improved, with the possibility of moving towards long-term remission or even clinical cure greatly increased.
Preliminary clinical trial results indicate that off-the-shelf universal CAR-DNT cell therapy(RJMty19 Injection)With its "ready-to-use" convenience, good safety, and encouraging deep and lasting relief effects, it shows potential in improving the prognosis of patients with high tumor burden and multiple lines of treatment failure.
(Note: The content of this article is based on publicly available clinical trial cases, and is only intended for sharing medical research progress. It does not constitute treatment recommendations. Please follow your doctor's advice for specific treatment plans.)
Editor in charge: Xuan Xiao
Proofread by | Xuan Xiao
References:
1.Zhejiang Ruishun Biotech Co., Ltd. Official WeChat
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