BCMA × CD3 bispecific T-cell engager · relapsed/refractory multiple myeloma Phase III clinical trial
Official protocol title:A Phase III, Multicenter, Randomized, Open-Label Study Comparing Etentamig with Available Standard of Care Therapies in Participants with Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)
Trial Summary
This is a sponsor-initiated Phase III clinical trial conducted by AbbVie in adult participants with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy, which must have included a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. The study regimen evaluates the activity and safety of intravenous infusions of the innovative biologic agent ABBV-383 (etentamig) monotherapy administered in 4-week treatment cycles compared with available standard of care therapies. The trial is being conducted at 19 medical institutions in China—including the Institute of Hematology & Blood Diseases Hospital (Chinese Academy of Medical Sciences), Peking Union Medical College Hospital, Beijing Chaoyang Hospital of Capital Medical University, The First Affiliated Hospital of Soochow University, and Sun Yat-sen University Cancer Center—as well as across medical centers in 14 countries including Japan, the United Kingdom, Germany, Australia, and Sweden.
Participating Centers2 in China + 17 overseas
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
- CTR20242452
- Verify on the NMPA CDE public platformby entering CTR20242452 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
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 ≤ 2, ≥ 2 prior lines of therapy. The study specifies 19 inclusion and 19 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 [BCMA × CD3 bispecific T-cell engager (BiTE)]. 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 2 study centres in China and 17 overseas centres. The lead institution is [The First Affiliated Hospital of Nanchang University]. Prominent sites include The First Affiliated Hospital of Nanchang University, Shanghai Tongji Hospital, Sun Yat-sen University Cancer Center, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20242452] (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
BCMA × CD3 bispecific T-cell engager (BiTE)
Sponsor
AbbVie Pharmaceutical Trading (Shanghai) Co., Ltd.
Principal Investigator
Fei Li
Lead Institution
The First Affiliated Hospital of Nanchang University
Participating Centers
2 in China + 17 overseas
CDE Registry ID
CTR20242452
ClinicalTrials.gov ID
NCT06158841Trial 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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