Trispecific antibody targeting BCMA, GPRC5D, a… · relapsed/refractory multiple myeloma Phase I/II clinical trial
Official protocol title:A Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MBS314 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma
Trial Summary
This project is a single-arm Phase I/II clinical trial jointly sponsored by Kangyuan Bochuang Biotechnology (Beijing) Co., Ltd. and Beijing Mabworks Biotech Co., Ltd., primarily targeting patients with relapsed/refractory multiple myeloma (RRMM). The treatment regimen utilizes a novel biological product (antibody drug), MBS314 injection; specific dosages and courses of treatment will be administered strictly according to the protocol. This study is a domestic trial without international medical center participation and is currently being conducted in 11 leading hematology and core oncology hospitals across China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Blood Diseases Hospital), Beijing Chaoyang Hospital affiliated to Capital Medical University, Sun Yat-sen University Cancer Center, The First Affiliated Hospital, Zhejiang University School of Medicine, and Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Participating Centers0 in China + 11 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
- CTR20240206
- Verify on the NMPA CDE public platformby entering CTR20240206 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 [Relapsed/refractory]. 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 7 inclusion and 11 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 [Trispecific antibody targeting BCMA, GPRC5D, and CD3]. 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/II] 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 11 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Beijing Chaoyang Hospital, Capital Medical University, Sun Yat-sen University Cancer Center, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20240206] (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/II
Target / Therapy
Trispecific antibody targeting BCMA, GPRC5D, and CD3
Sponsor
Kangyuan Bochuang Biotechnology (Beijing) Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
0 in China + 11 overseas
CDE Registry ID
CTR20240206
ClinicalTrials.gov ID
NCT06232096Trial 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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