GPRC5D/CD3 bispecific antibody · relapsed/refractory multiple myeloma Phase III clinical trial
Official protocol title:A Randomized, Controlled, Multicenter, Open-Label Phase III Study Evaluating the Efficacy and Safety of QLS32015 for Injection Monotherapy Versus Investigator's Choice of Regimen in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
Trial Summary
This project is a Phase III clinical trial sponsored by Qilu Pharmaceutical, primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) who have failed or are intolerant to ≥3 prior lines of therapy. The treatment regimen compares a biologic/T-cell redirecting therapy (QLS32015 for injection monotherapy, administered subcutaneously once every 2 weeks) versus investigator's choice of regimen (such as the immunomodulatory agent pomalidomide, given in 28-day cycles with 21 days on and 7 days off). The trial is conducted across a total of 82 top domestic hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), Peking University Third Hospital, Qilu Hospital of Shandong University, Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, and Beijing Chaoyang Hospital affiliated to Capital Medical University.
Participating Centers1 in China + 81 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
- CTR20253381
- Verify on the NMPA CDE public platformby entering CTR20253381 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, ≥ 3 prior lines of therapy. The study specifies 11 inclusion and 16 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/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 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 1 study centres in China and 81 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, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, First Affiliated Hospital of Kunming Medical University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20253381] (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
GPRC5D/CD3 bispecific antibody
Sponsor
Qilu Pharmaceutical Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
1 in China + 81 overseas
CDE Registry ID
CTR20253381
ClinicalTrials.gov ID
NCT07138209Trial 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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