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
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
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
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, ≥ 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.
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.
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 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.
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.
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
NCT07764861Trial 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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International participation must be confirmed directly with the study team. If a clinical trial is not practical, review our independent guide to CAR-T in China.
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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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