BCMA × CD3-targeting bispecific antibody · multiple myeloma Phase I clinical trial
Official protocol title:An Open-Label, Multicenter Phase I Clinical Study of SHR-9539 Injection Evaluating Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Patients with Multiple Myeloma
Trial Summary
This project is a Phase I clinical trial sponsored by Hengrui Medicine (Suzhou Suncadia Biopharmaceuticals Co., Ltd. / Shanghai Hengrui Pharmaceutical Co., Ltd.), primarily targeting patients diagnosed with active multiple myeloma according to IMWG criteria (with no restrictions on prior lines of therapy or specific gene mutation requirements). The treatment regimen utilizes the innovative biological product SHR-9539 injection as monotherapy via subcutaneous injection, administered in cycles of 21 days (dosed on Days 1, 8, and 15) or 28 days (dosed on Days 1 and 15), with continuous administration until intolerable adverse reactions or disease progression occur. This trial is a domestic study conducted across a total of 29 top core domestic hospitals, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), West China Hospital of Sichuan University, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, and Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Participating Centers1 in China + 27 overseas
Source and Verification
Every fact on this page is derived from the official study protocol document below. The source document is archived as a PDF for direct verification.
- Document type
- CDE clinical trial registration filing (original PDF)
- Official registration number
- CTR20242335
- Verify on the NMPA CDE public platformby entering CTR20242335 in the registration-number field. The platform is a search interface with no permanent per-study URL, so a direct link is not possible.
- Last reconciled
- 2026-09-07
Frequently Asked Questions about this Study
Structured facts derived from official protocol filings for patient and family reference
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 years, ECOG performance status ≤ 1. The study specifies 6 inclusion and 8 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 [BCMA × CD3-targeting bispecific antibody]. 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 1 study centres in China and 27 overseas centres. The lead institution is [West China Hospital of Sichuan University]. Prominent sites include West China Hospital of Sichuan University, The First Affiliated Hospital, Zhejiang University School of Medicine, Shengjing Hospital of China Medical University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20242335] (CDE_CTR). Patients and researchers can verify registration details and regulatory authorizations directly on the official NMPA CDE platform.
Key Information
Status
Recruiting
Phase
Phase I
Target / Therapy
BCMA × CD3-targeting bispecific antibody
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Principal Investigator
Ting Niu
Lead Institution
West China Hospital of Sichuan University
Participating Centers
1 in China + 27 overseas
CDE Registry ID
CTR20242335
ClinicalTrials.gov ID
NCT06484777Trial information is translated from the Chinese source record and reviewed by CMDN. Confirm current status and eligibility with the study team.
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Protocol drugs and related tests are fully covered by the sponsor. All studies are strictly supervised by ethics committees, and patients retain the legal right to withdraw at any time.
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