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
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
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
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 6 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 [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.
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.
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.
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.
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
NCT07623798Trial 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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