GPRC5D-targeted CAR-T · relapsed/refractory multiple myeloma Phase Ib/II clinical trial
Official protocol title:An Open-Label, Multicenter Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of OriCAR-017 in Participants with Relapsed/Refractory Multiple Myeloma (MERCURY)
Trial Summary
This project is a Phase Ib/II clinical trial sponsored by OrigiCell Therapeutics (Shanghai) Co., Ltd., primarily enrolling patients with relapsed/refractory multiple myeloma (RRMM) who have failed prior treatment with at least three regimens of different mechanisms of action (an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody), and have confirmed bone marrow plasma cell membrane GPRC5D expression >= 20%. The treatment regimen employs a GPRC5D-targeted chimeric antigen receptor T-cell (CAR-T) therapy (OriCAR-017) administered as a single intravenous infusion. The trial is currently being conducted across 8 domestic core hematology hospitals in China, including The First Affiliated Hospital, Zhejiang University School of Medicine; Shanghai Tongji Hospital; Jiangsu Province Hospital; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; and Sun Yat-sen University Cancer Center.
Participating Centers0 in China + 8 overseas
Source and Verification
Every fact on this page is derived from the original filing below. The source document is archived as a PDF for direct verification.
- Document type
- CDE clinical trial registration filing (original PDF)
- Official registration number
- CTR20232814
- Verify on the NMPA CDE public platformby entering CTR20232814 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
- 2026-09-04
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. The study specifies 11 inclusion and 26 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-targeted CAR-T]. 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 Ib/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 8 overseas centres. The lead institution is [The First Affiliated Hospital, Zhejiang University School of Medicine]. Prominent sites include The First Affiliated Hospital, Zhejiang University School of Medicine, Shanghai Tongji Hospital, Jiangsu Province Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20232814] (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 Ib/II
Target / Therapy
GPRC5D-targeted CAR-T
Sponsor
OrigiCell Therapeutics (Shanghai) Co., Ltd.
Principal Investigator
He Huang
Lead Institution
The First Affiliated Hospital, Zhejiang University School of Medicine
Participating Centers
0 in China + 8 overseas
CDE Registry ID
CTR20232814
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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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.
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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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