Second-generation BCL-2 inhibitor · relapsed/refractory multiple myeloma Phase 1b/2 clinical trial
Official protocol title:A Phase 1b/2, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety and Efficacy of BGB-11417 Monotherapy, BGB-11417 in Combination With Dexamethasone, and BGB-11417 in Combination With Dexamethasone and Carfilzomib, Dexamethasone and Daratumumab, and Dexamethasone and Pomalidomide in Patients With Relapsed/Refractory Multiple Myeloma Harboring t(11;14)
Trial Summary
This is a Phase 1b/2 clinical trial sponsored by BeiGene, primarily for patients with relapsed/refractory multiple myeloma (RRMM) who have received at least 1 prior line or 3 or more prior lines of therapy (including prior exposure to a proteasome inhibitor, an immunomodulatory drug, or an anti-CD38 monoclonal antibody, etc.) and are confirmed positive for the t(11;14) translocation by FISH. Treatment regimens include the BCL-2 inhibitor (BGB-11417/Sonrotoclax) as monotherapy or in various combinations with a glucocorticoid (dexamethasone), a proteasome inhibitor (carfilzomib), an anti-CD38 monoclonal antibody (daratumumab), and an immunomodulatory drug (pomalidomide). BGB-11417 is administered orally once daily in continuous cycles until disease progression or unacceptable toxicity. The trial is being conducted across a total of 24 top domestic hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), Peking University People's Hospital, Zhongshan Hospital Fudan University, The First Affiliated Hospital, Zhejiang University School of Medicine, and Guangdong Provincial People's Hospital, and is concurrently ongoing at 70 leading international medical centers across 14 countries including the United States, United Kingdom, France, Germany, and Australia.
Participating Centers1 in China + 23 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
- CTR20231932
- Verify on the NMPA CDE public platformby entering CTR20231932 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, ≥ 1 prior lines of therapy. The study specifies 13 inclusion and 20 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 [Second-generation BCL-2 inhibitor (oral small molecule targeted agent)]. 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 1b/2] 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 23 overseas centres. The lead institution is [Peking University People's Hospital]. Prominent sites include Peking University People's Hospital, Fujian Medical University Union Hospital, Henan Cancer Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20231932] (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 1b/2
Target / Therapy
Second-generation BCL-2 inhibitor (oral small molecule targeted agent)
Sponsor
BeiGene (Suzhou) Co., Ltd.
Principal Investigator
Jin Lu
Lead Institution
Peking University People's Hospital
Participating Centers
1 in China + 23 overseas
CDE Registry ID
CTR20231932
ClinicalTrials.gov ID
NCT04973605Trial 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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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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