RecruitingPhase I/IICTR20243384Trispecific antibody targeting GPRC5D, BCMA, and CD3

Trispecific antibody targeting GPRC5D, BCMA, a… · relapsed/refractory multiple myeloma Phase I/II clinical trial

Official protocol title:A Phase I/II, Multicenter, Open-Label Study of IBI3003 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 project is a Phase I/II clinical trial sponsored by Innovent Biologics, primarily targeting patients with relapsed or refractory multiple myeloma who have received at least 2 prior lines of therapy (and must have previously received at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38-based therapy). The treatment regimen utilizes an innovative biologic product (IBI3003 injection) administered according to the participant's body weight, with continuous treatment until disease progression, unacceptable toxicity, or a maximum routine treatment period of 24 months (patients deriving clinical benefit may continue treatment upon evaluation). This study is an international multicenter trial, currently with a total of 23 leading general and specialized hospitals participating in China, including core hematology diagnosis and treatment institutions such as the First Affiliated Hospital of Soochow University, the First Affiliated Hospital, Zhejiang University School of Medicine, Beijing Chaoyang Hospital, Capital Medical University, Tianjin Medical University General Hospital, and Xiangya Hospital Central South University.

Participating Centers0 in China + 23 overseas

Zhongshan Hospital, Fudan University
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First Affiliated Hospital of Xi'an Jiaotong University
The Affiliated Hospital of Xuzhou Medical University
The First Affiliated Hospital of Guangxi Medical University
Tianjin Medical University General Hospital
The First Affiliated Hospital of Soochow University
Jiangsu Province Hospital
The First Affiliated Hospital, Zhejiang University School of Medicine
Henan Cancer Hospital
The First Affiliated Hospital of Nanchang University
The First Affiliated Hospital of Jinan University
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Xiangya Hospital, Central South University
The Second Affiliated Hospital of Anhui Medical University
Harbin Medical University Cancer Hospital
Affiliated Hospital of Jining Medical University
The First Affiliated Hospital of Fujian Medical University
The First Affiliated Hospital of Zhengzhou University
Nanfang Hospital, Southern Medical University
Beijing Chaoyang Hospital, Capital Medical University
Tianjin Medical University Cancer Institute and Hospital
The Second Affiliated Hospital, Zhejiang University School of Medicine

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
CTR20243384
Verify on the NMPA CDE public platformby entering CTR20243384 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, ≥ 2 prior lines of therapy. The study specifies 7 inclusion and 7 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 GPRC5D, BCMA, 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 23 overseas centres. The lead institution is [Zhongshan Hospital, Fudan University]. Prominent sites include Zhongshan Hospital, Fudan University, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital of Xi'an Jiaotong University, 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 [CTR20243384] (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 GPRC5D, BCMA, and CD3

Sponsor

Innovent Biologics (Suzhou) Co., Ltd.

Principal Investigator

Peng Liu

Lead Institution

Zhongshan Hospital, Fudan University

Participating Centers

0 in China + 23 overseas

CDE Registry ID

CTR20243384

ClinicalTrials.gov ID

NCT07764861

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

Innovent BiologicsPhase I/IImultiple myelomabiologic productIBI3003proteasome inhibitorimmunomodulatory druganti-CD38 antibodyprior multiple lines of therapyCTR20243384

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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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