RecruitingPhase IIICTR20262035GPRC5D/BCMA/CD3 trispecific antibody

GPRC5D/BCMA/CD3 trispecific antibody · relapsed/refractory multiple myeloma Phase III clinical trial

Official protocol title:A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Study of IBI3003 Versus Investigator's Choice of Regimen (DPd or PVd) on the Efficacy and Safety in Participants with Relapsed or Refractory Multiple Myeloma

Sponsor: Innovent Biologics (Suzhou) Co., Ltd.Updated: 9/4/2026
Target CohortRelapsed/refractory(Synthesized by CMDN from protocol summary; final eligibility confirmed by study doctors)

Trial Summary

This study is a multicenter, randomized, controlled, open-label Phase III clinical study in patients with relapsed or refractory multiple myeloma. The study aims to evaluate the efficacy and safety of IBI3003 compared with investigator's choice of regimen (DPd or PVd). The trial is open to participants aged 18 and older who meet the eligibility criteria, and is conducted across multiple hospitals including Zhongshan Hospital, Fudan University.

Participating Centers1 in China + 44 overseas

Zhongshan Hospital, Fudan University
The First Affiliated Hospital, Zhejiang University School of Medicine
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
The Affiliated Hospital of Xuzhou Medical University
The Second Affiliated Hospital, Zhejiang University School of Medicine
Henan Cancer Hospital
The First Affiliated Hospital of Nanchang University
Beijing Chaoyang Hospital, Capital Medical University
The First Affiliated Hospital of Jinan University
Tianjin Medical University Cancer Institute and Hospital
Affiliated Hospital of Jining Medical University
The First Affiliated Hospital of Zhengzhou University
Jiangsu Province Hospital
The Second Xiangya Hospital of Central South University
The Third Xiangya Hospital of Central South University
Shandong Provincial Hospital
Harbin Medical University Cancer Hospital
Qilu Hospital of Shandong University
Yunnan Cancer Hospital
Tianjin First Central Hospital
Sun Yat-sen University Cancer Center
Shanghai Fourth People's Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Zhongshan Hospital, Xiamen University
Xinqiao Hospital, Army Medical University
Shandong Cancer Hospital
Anhui Provincial Cancer Hospital
The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Henan University of Science and Technology
Shengjing Hospital of China Medical University
The First Hospital of Jilin University
Affiliated Hospital of Nantong University
Shanghai Changzheng Hospital
Fujian Medical University Union Hospital
Shanghai Sixth People's Hospital
Tongji Hospital of Tongji University
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Jiangxi Cancer Hospital
The First Affiliated Hospital of Guangxi Medical University
The First Affiliated Hospital of Harbin Medical University
Peking University First Hospital
Peking University People's Hospital
Guangdong Provincial People's Hospital
The Fourth Hospital of Hebei Medical University
The Affiliated Hospital of Inner Mongolia Medical University

Source and Verification

Every fact on this page is derived from the original filing below. The source document is archived as a PDF for direct verification.

Document type
CDE clinical trial registration filing (original PDF)
Official registration number
CTR20262035
Verify on the NMPA CDE public platformby entering CTR20262035 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
2026-09-04

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 6 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 [GPRC5D/BCMA/CD3 trispecific antibody]. 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 III] 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 1 study centres in China and 44 overseas centres. The lead institution is [Zhongshan Hospital, Fudan University]. Prominent sites include Zhongshan Hospital, Fudan University, The First Affiliated Hospital, Zhejiang University School of Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 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 [CTR20262035] (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 III

Target / Therapy

GPRC5D/BCMA/CD3 trispecific antibody

Sponsor

Innovent Biologics (Suzhou) Co., Ltd.

Principal Investigator

Peng Liu

Lead Institution

Zhongshan Hospital, Fudan University

Participating Centers

1 in China + 44 overseas

CDE Registry ID

CTR20262035

CDE Registry ID

CTR20243384

Internal Protocol ID

CIBI3003A301

ClinicalTrials.gov ID

NCT07623798

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

IBI3003relapsed/refractory multiple myeloma (RRMM)DPdPVdPhase III

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