BCMA × CD3 bispecific antibody · relapsed/refractory multiple myeloma Phase II clinical trial
Official protocol title:An Open-Label, Single-Arm, Phase II Clinical Study Evaluating CX13-608 in Participants with Relapsed or Refractory Multiple Myeloma
Trial Summary
This project is a Phase II clinical trial sponsored by Ningbo Shengjian Biotechnology Co., Ltd., primarily targeting patients with multiple myeloma who have received at least 2 prior therapy regimens (which must include an alkylating agent or anthracyclines, bortezomib, and an immunomodulatory drug) and have demonstrated relapsed/refractory disease to their most recent regimen. The treatment regimen utilizes the chemical drug CX13-608 (intravenous) in combination with low-dose dexamethasone (oral), administered in 28-day treatment cycles (administered 3 days per week for 3 consecutive weeks, with rest in week 4), with continuous treatment. The trial is conducted across a total of 10 top domestic hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Peking University Third Hospital, and Sun Yat-sen University Cancer Center.
Participating Centers0 in China + 10 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
- CTR20202322
- Verify on the NMPA CDE public platformby entering CTR20202322 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 18–75 years, ECOG performance status ≤ 2, ≥ 2 prior lines of therapy. The study specifies 15 inclusion and 27 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 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 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 10 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20202322] (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 II
Target / Therapy
BCMA × CD3 bispecific antibody
Sponsor
Ningbo Shengjian Biotechnology Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
0 in China + 10 overseas
CDE Registry ID
CTR20202322
Trial 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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