Keyi Pharma's Dual-Target CAR-T Therapy KQ-2003 Enters Phase I/IIa Clinical Trial at Peking Union Medical College Hospital

Recently, by Novatim Immune Therapeutics (Zhejiang) Co., Ltd.'s wholly-owned subsidiary——The First Clinical Trial Center Launch Meeting for the Phase I/IIa Clinical Study of "KQ-2003 CAR-T Cell Injection," a Next-Generation CAR-T Product Independently Developed by Novatim, in Relapsed/Refractory Multiple Myeloma Patients to Evaluate Safety, Tolerance, Preliminary Efficacy, and Pharmacokinetic Characteristics was Successfully Held at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, the Lead Institution., officially entering the patient recruitment phase.

Director Li Jian, Chief of the Department of Hematology at Peking Union Medical College Hospital and doctoral supervisor, along with his research team, and the sponsor team from Novatim Immune Therapeutics (Zhejiang) Co., Ltd., jointly attended this meeting.

This clinical trial is led by Director Li Jian, the principal investigator (leading PI), who is the director of the Department of Hematology at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and a doctoral supervisor.Director Li JianStated: "KQ-2003, a dual-target CAR-T therapy, has greater therapeutic potential compared to single-target products. As the principal investigator of this project, we are highly optimistic about its future clinical potential and the selection of differentiated indications. We will also lead influential research institutions across China in this disease area, working together to bring more new hope to the treatment of patients with hematological malignancies."

About KQ-2003

KQ-2003 is a next-generation CAR-T product independently developed from the source by Novatim, which can simultaneously target two therapeutic antigens, B-cell maturation antigen (BCMA) and CD19. It will bring new treatment hope and deep, long-lasting therapeutic effects to more patients with relapsed/refractory multiple myeloma in the future.。

As of the initiation date, there are 10 evaluable patients in the IIT study of KQ-2003 CAR-T Cell Injection for the treatment of relapsed/refractory multiple myeloma. Among these 10 evaluable patients, the overall response rate (ORR) is 100%, with 5 patients achieving complete response (CR) and 5 patients achieving very good partial response (VGPR). The longest progression-free survival (PFS) has been maintained for 21 months. No cytokine release syndrome (CRS) of grade 3 or higher has occurred. Preliminary data indicate that KQ-2003 CAR-T Cell Injection demonstrates favorable safety and efficacy.