RecruitingPhase I/IICTR20240206Trispecific antibody targeting BCMA, GPRC5D, and CD3

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

Sponsor: Kangyuan Bochuang Biotechnology (Beijing) Co., Ltd.Updated: 9/7/2026
Target CohortRelapsed/refractory(Synthesized by CMDN from protocol summary; final eligibility confirmed by study doctors)

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

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Beijing Chaoyang Hospital, Capital Medical University
Sun Yat-sen University Cancer Center
Shandong Cancer Hospital
The First Affiliated Hospital, Zhejiang University School of Medicine
The First Hospital of Jilin University
Nanfang Hospital, Southern Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First Affiliated Hospital of Xiamen University
Xiangya Hospital, Central South University
Hunan Cancer Hospital

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

QWhich patient group is targeted by this 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 [Relapsed/refractory]. Eligibility requires verified clinical confirmation by investigators regarding prior lines of therapy, active disease biomarkers, and performance status.

QWhat are the specific eligibility criteria regarding age, performance status, and prior therapy?

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.

QWhat are the investigational targets and mechanism of action?

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.

QWhat clinical phase is this study in?

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.

QWhere are the participating hospital trial centers located?

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.

QWhat is the official trial registration code and how can it be verified?

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.

Note for International Patients: Trial centers for this study are located in China. Interventional trials strictly comply with domestic Human Genetic Resources (HGRAC) regulations and standard hospital protocols, which generally restrict enrollment to residents with domestic healthcare identification. International patients seeking approved cellular therapies should review commercial options.

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

NCT06232096

Trial information is translated from the Chinese source record and reviewed by CMDN. Confirm current status and eligibility with the study team.

Where this study sits in the landscape

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Keywords

Kangyuan BochuangBeijing MabworksPhase I/IIrelapsed/refractory multiple myelomabiological productsantibody drugsMBS314CTR20240206

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Patient Rights & Safety Assurance

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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