T-cell redirecting bispecific antibody · relapsed/refractory multiple myeloma Phase II clinical trial
Official protocol title:A Single-Arm, Open-Label, Multicenter Phase II Clinical Trial of GR1803 Injection Evaluating the Efficacy, Safety, Pharmacokinetics, and Immunogenicity in Patients with Relapsed/Refractory Multiple Myeloma Complicated by Extramedullary Disease
Trial Summary
This project is a single-arm Phase II clinical trial sponsored by Chongqing Zhixiang Jintai Biopharmaceutical, primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) complicated by extramedullary disease who have received at least 1 prior line of therapy for multiple myeloma (must have received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody). The treatment regimen utilizes the novel biologic product GR1803 injection (a BCMA-targeted agent) administered in 4-week treatment cycles (once weekly for the first 9 cycles, then once every 2 weeks thereafter) until disease progression. This trial is a domestic multicenter study, with the currently announced lead institution being the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology).
Participating Centers0 in China + 1 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
- CTR20250844
- Verify on the NMPA CDE public platformby entering CTR20250844 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 7 inclusion and 23 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 [T-cell redirecting 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 1 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology)]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology). Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20250844] (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
T-cell redirecting bispecific antibody
Sponsor
Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd.
Principal Investigator
Gang An
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology)
Participating Centers
0 in China + 1 overseas
CDE Registry ID
CTR20250844
ClinicalTrials.gov ID
NCT07090954Trial information is translated from the Chinese source record and reviewed by CMDN. Confirm current status and eligibility with the study team.
Where this study sits in the landscape
Browse comparable active studies by disease stage, modality and province
Keywords
Considering a non-trial option?
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.
View CAR-T in China Guide →Evidence · Process · Costs · Verified hospitals
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.
Read application guide & patient rights