Recently, the first clinical trial center kick-off meeting for the I/IIa phase clinical study on the safety, tolerability, preliminary efficacy and pharmacokinetic characteristics of the new-generation CAR-T product "KQ-2003 CAR-T Cell Injection" in patients with relapsed/refractory multiple myeloma, independently developed from the source by Shanghai Tinova Immune Therapeutics Co., Ltd., a wholly-owned subsidiary of Novatim Immune Therapeutics (Zhejiang)Co.,Ltd, was successfully held at the leading institution, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. The study has officially entered the patient recruitment and enrollment stage.
The meeting was attended by Director Li Jian, the head of the Department of Hematology at Peking Union Medical College Hospital and a doctoral supervisor, his research team, the team from the sponsor company, Novatim, and representatives from the contract research organization (CRO), Tigermed.
This clinical trial is led by Dr. Li Jian, the director of the Department of Hematology at Peking Union Medical College Hospital and a doctoral supervisor, who serves as the leading principal investigator (leading PI). Dr. Li Jian stated: "KQ-2003, as a dual-target CAR-T, has better therapeutic potential compared to single-target products. As the leading principal investigator of this project, we are very optimistic about its future clinical potential and the selection of differentiated indications. We will also lead influential research institutions across the country to work together to bring more new hope for the treatment of hematological malignancies."
Regarding KQ-2003
KQ-2003 is a new-generation CAR-T product independently developed from the source. It can target both B-cell maturation antigen (BCMA) and CD19 as therapeutic targets simultaneously. In the future, it will bring new treatment hope and profound and lasting therapeutic effects to more patients with relapsed/refractory multiple myeloma.
As of the launch date, there have been 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) was 100%, with 5 achieving complete remission (CR) and 5 achieving very good partial remission (VGPR). The longest progression-free survival (PFS) was maintained for 21 months. No grade 3 or above cytokine release syndrome (CRS) occurred. The preliminary data available indicate that KQ-2003 CAR-T cell injection is safe and effective.
