Subject recruitment
GT919 for POMES Syndrome
On December 20, 2022, GT919, a molecular glue pipeline drug developed by Biotech Innovation, was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to enter Phase I clinical trials. On July 24, 2023, GT919 completed the enrollment of the first patient. On March 12, 2024, it was approved to conduct a Phase I clinical trial of GT919 combined with dexamethasone. On March 3, 2025, it was approved to conduct a clinical trial of GT919 combined with dexamethasone in patients with relapsed/refractory POEMS syndrome.
Recruitment Criteria:
You may be eligible to participate in this study if you meet the following main criteria：
- Men or women, aged >18 years;
- Definitively diagnosed with POEMS syndrome;
- Have received at least one prior line of systemic therapy;
- Serum vascular endothelial growth factor (VEGF) level ≥ 1200 ng/L;
- Overall Neuropathy Limitations Scale (ONLS) score ≥ 1;
- ECOG performance status score of 0-2;
- Have adequate bone marrow reserve and organ function;
- Fertile subjects must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose.
Participating Research Centers:
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
- Renji Hospital, Shanghai Jiao Tong University School of Medicine
- The First Affiliated Hospital, Zhejiang University School of Medicine
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- West China Hospital, Sichuan University
- Xiangya Hospital, Central South University
- Nanfang Hospital, Southern Medical University
Diagnosis and Treatment Guidelines:
Chinese Expert Consensus on the Diagnosis and Treatment of POEMS Syndrome (2025 Edition)