Domestic biosimilar of daratumumab · multiple myeloma Phase I clinical trial

According to official protocol filings (target population synthesized by CMDN from study details, not an official CDE field), this study is primarily designed for patients with [Multiple myeloma]. Eligibility requires verified clinical confirmation by investigators regarding prior lines of therapy, active disease biomarkers, and performance status.

According to verified protocol filings, key eligibility thresholds include: age 18–50 years, acceptable performance status. The study specifies 4 inclusion and 15 exclusion criteria covering detailed organ function and medical history. Final enrollment confirmation is determined by investigators at participating hospital trial centers.

The core therapeutic target or investigational mechanism is [Domestic biosimilar of daratumumab]. It aims to selectively eradicate clonal plasma cells or redirect anti-tumor immune responses, representing an active area of precision hematology research.

This study is registered as a [Phase I] clinical trial. The protocol is conducted under rigorous ethical and Good Clinical Practice (GCP) oversight approved by institutional ethics committees.

This is an international multi-centre study with 0 study centres in China and 2 overseas centres. The lead institution is [The First Affiliated Hospital, Zhejiang University School of Medicine]. Prominent sites include The First Affiliated Hospital, Zhejiang University School of Medicine, The Second Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army. Eligible domestic patients can seek screening at the nearest participating centre.

The official public registration identifier for this protocol is [CTR20241093] (CDE_CTR). Patients and researchers can verify registration details and regulatory authorizations directly on the official NMPA CDE platform.