Jiabao Yaoyin Announces Successful Launch of Phase I Clinical Trial of BTK Inhibitor JDB175 for Relapsed/Refractory Central Nervous System Lymphoma

Central nervous system (CNS) lymphoma is among the most devastating diseases that remain poorly treated. Compared with other therapeutic areas, the blood–brain barrier impedes the delivery of 98% of drugs to CNS lesions, resulting in lower success rates and longer development timelines for CNS-targeted therapies, thereby severely limiting treatment options for CNS lymphoma. Patients with relapsed/refractory CNS lymphoma have short survival times and poor prognoses. Currently, no drugs have been approved in China for this indication, leaving patients with very limited therapeutic options; participation in clinical trials may even represent the best choice for these patients.

The clinical initiation meeting was recently held for the multicenter Phase I clinical trial, “An Open-Label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of JDB175 Monotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma,” jointly initiated by Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and West China Hospital, Sichuan University.

Academician Wei Yuquan, founder of Jiabao Yaoyin, extended his congratulations on the successful initiation of the Phase I clinical study of JDB175. The site initiation meetings at the two centers were chaired respectively by Professor Zhao Weili, Director of the Department of Hematology at Shanghai Ruijin Hospital, and Professor Niu Ting, Director of the Department of Hematology at West China Hospital, Sichuan University, who serve as the principal investigators for the project. They provided detailed introductions to the preclinical pharmacological and efficacy characteristics of JDB175, summarized and compared its non-clinical research results with those of similar drugs, and highlighted that JDB175 possesses substantial potential for clinical development.

Subsequently, Dr. Zhang Qi, Head of Medicine at Jiabao Yaoyin, provided a detailed introduction to the study protocol, including the research background, study design, inclusion and exclusion criteria, withdrawal and termination criteria, and evaluation endpoints.

Professor Zhao Weili led the project research team, along with professionals from the Departments of Imaging and Radiology, in discussions on key aspects of trial protocol implementation and risk control during the study.

Professor Niu Ting's Teamand Secretary WuMaProfessorA detailed discussion was held with Director Zheng Li of the CTC Center at West China Hospital and Professor Miao Jia, who is responsible for project management, regarding the protocol content and key considerations during implementation, laying a solid foundation for the smooth conduct of this clinical trial in the future.

Finally, the teams led by Professor Zhao Weili and Professor Niu Ting both extended their congratulations on the successful launch of the Phase I clinical trial for the JDB175 project. They expressed strong confidence in their participation and high expectations for the drug’s clinical safety and efficacy.

JDB175 is a highly selective, second-generation oral inhibitor of Bruton's tyrosine kinase (BTK), a key protein molecule in the B-cell receptor pathway that participates in B-cell proliferation, trafficking, chemotaxis, and adhesion, and is widely expressed in various types of hematologic malignancies. Preclinical studies have demonstrated that JDB175 offers significant advantages in blood-brain barrier penetration compared to similar drugs, while maintaining potent and selective BTK inhibition. As existing BTK inhibitors generally exhibit poor brain penetration, their application in central nervous system (CNS) B-cell disorders has been severely limited. Consequently, the clinical development of JDB175 will focus primarily on the CNS field, holding substantial clinical value and social significance.

Key Inclusion Criteria:

(1) Voluntarily participate in this trial and sign the informed consent form;

(2) Age >18 years, no gender restriction;

(3) Refractory/RelapsedDiffuse large B-cell lymphoma (not otherwise specified);

(4) Relapsed/RefractoryPrimary Central Nervous System Diffuse Large B-Cell Lymphoma (PCNS-DLBCL);

(5) Relapsed/RefractoryThe primary lesion was previously confirmed as B-cell-derived secondary central nervous system lymphoma (SCNSL);

(6) During screening, subjects must provide their most recent tumor tissue or undergo a tumor tissue biopsy;

(7) Eastern Cooperative Oncology Group (ECOG) performance status at screening: 0–2;

(8) Estimated life expectancy ≥16 weeks;

(9) At least one measurable lesion.

Eligible patients are welcome to join the study. Contact information is as follows:

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Teacher Hu 180 1627 8716

West China Hospital, Sichuan University

Teacher Wang 139 8184 0550