BCMA-targeting bispecific antibody · relapsed/refractory multiple myeloma Phase III clinical trial
Official protocol title:A Multicenter, Open-label, Randomized Phase III Clinical Trial Comparing the Efficacy and Safety of GR1803 Injection Versus Daratumumab + Pomalidomide + Dexamethasone in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) Who Have Received 1-3 Prior Lines of Therapy (Including Lenalidomide and a Proteasome Inhibitor)
Trial Summary
This project is a phase III clinical trial sponsored by Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd., primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) who have received 1-3 prior lines of therapy (which must include lenalidomide and a proteasome inhibitor; if only 1 prior line was received, the disease must be refractory to lenalidomide). The treatment regimen randomizes patients into two groups to receive either the innovative biologic GR1803 injection, or combination therapy consisting of daratumumab (anti-CD38 monoclonal antibody), pomalidomide (immunomodulator), and dexamethasone (glucocorticoid). Drugs are administered in regular cycles (gradually transitioning from initial weekly administration to administration every four weeks), continuing treatment until disease progression or intolerable toxicity. This project is currently widely conducted across 68 top domestic hospitals, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), Peking Union Medical College Hospital, Beijing Chaoyang Hospital Affiliated to Capital Medical University, The First Affiliated Hospital of Soochow University, and Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
Participating Centers2 in China + 65 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
- CTR20260453
- Verify on the NMPA CDE public platformby entering CTR20260453 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, 1–3 prior lines of therapy. The study specifies 7 inclusion and 24 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-targeting 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 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 65 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, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 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 [CTR20260453] (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-targeting bispecific antibody
Sponsor
Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
2 in China + 65 overseas
CDE Registry ID
CTR20260453
ClinicalTrials.gov ID
NCT07452198Trial 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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