GPRC5D × BCMA × CD3 trispecific antibody · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A First-in-Human (FIH), Open-Label, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of the Humanized GPRC5D-BCMA-CD3 Trispecific Antibody SIM0500 in Participants with Relapsed or Refractory Multiple Myeloma
Trial Summary
This project is an open-label, Phase I (first-in-human) clinical trial sponsored by Shanghai Xianxiang Pharmaceutical Technology Co., Ltd., primarily targeting patients with relapsed or refractory multiple myeloma. The treatment regimen employs monotherapy with an innovative biologic, the GPRC5D-BCMA-CD3 trispecific antibody (SIM0500 for injection), administered according to protocol-specified doses and schedules. The trial is currently being conducted concurrently across a total of 7 leading domestic hematology hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), Sun Yat-sen University Cancer Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Beijing Chaoyang Hospital, Capital Medical University, and Nanjing Drum Tower Hospital, as well as 2 leading international medical centers in the United States.
Participating Centers0 in China + 7 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
- CTR20241358
- Verify on the NMPA CDE public platformby entering CTR20241358 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 ≤ 1. The study specifies 5 inclusion and 8 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 [GPRC5D × BCMA × CD3 trispecific 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 I] 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 7 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences), Sun Yat-sen University Cancer Center, 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 [CTR20241358] (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 I
Target / Therapy
GPRC5D × BCMA × CD3 trispecific antibody
Sponsor
Shanghai Xianxiang Pharmaceutical Technology Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)
Participating Centers
0 in China + 7 overseas
CDE Registry ID
CTR20241358
ClinicalTrials.gov ID
NCT06375044Trial 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