Trispecific antibody targeting BCMA, CD3, and… · relapsed/refractory multiple myeloma Phase I clinical trial
Official protocol title:A Phase I Clinical Trial of QLS4131 for Injection in Evaluating the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy in Patients with Relapsed or Refractory Multiple Myeloma
Trial Summary
This study is a Phase I clinical trial sponsored by Qilu Pharmaceutical Co., Ltd., primarily enrolling patients with relapsed or refractory multiple myeloma who have progressed on or are intolerant to established therapies. The treatment regimen utilizes monotherapy with the innovative biologic QLS4131 for injection (a T-cell redirecting therapeutic agent), administered via intravenous infusion or subcutaneous injection according to protocol-specified dosing and schedules to evaluate its safety and preliminary efficacy. The trial is currently being conducted in China across 15 prominent core hospitals, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), Tianjin Medical University Cancer Institute and Hospital, Sun Yat-sen University Cancer Center, Sichuan Provincial People's Hospital, and The Second Affiliated Hospital of Xi'an Jiaotong University.
Participating Centers1 in China + 14 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
- CTR20242686
- Verify on the NMPA CDE public platformby entering CTR20242686 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 11 inclusion and 15 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 [Trispecific antibody targeting BCMA, CD3, and GPRC5D]. 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 1 study centres in China and 14 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, Tianjin Medical University Cancer Institute and Hospital, Sichuan Provincial People's Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20242686] (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
Trispecific antibody targeting BCMA, CD3, and GPRC5D
Sponsor
Qilu Pharmaceutical Co., Ltd.
Principal Investigator
Gang An
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
1 in China + 14 overseas
CDE Registry ID
CTR20242686
ClinicalTrials.gov ID
NCT06500507Trial 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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