Trispecific antibody targeting BCMA, CD3, and… · multiple myeloma Phase II clinical trial
Official protocol title:A Multicenter, Open-Label Phase II Study Evaluating QLS4131 for Injection in Combination Therapy for the Treatment of Malignant Plasma Cell Neoplasms
Trial Summary
This study is a multicenter, open-label Phase II clinical trial evaluating the safety, tolerability, and preliminary efficacy of QLS4131 for injection in combination therapy in patients with malignant plasma cell neoplasms. The study plans to enroll participants aged 18 years and older with confirmed multiple myeloma, plasma cell leukemia, or primary light chain amyloidosis. The lead institution is Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and the study is conducted across multiple hospitals nationwide.
Participating Centers3 in China + 36 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
- CTR20261752
- Verify on the NMPA CDE public platformby entering CTR20261752 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
- 2026-09-03
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 [Multiple myeloma]. 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 21 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 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 3 study centres in China and 36 overseas centres. The lead institution is [Union Hospital, Tongji Medical College, Huazhong University of Science and Technology]. Prominent sites include Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Henan Cancer Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20261752] (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
Trispecific antibody targeting BCMA, CD3, and GPRC5D
Sponsor
Qilu Pharmaceutical Co., Ltd.
Principal Investigator
Yu Hu
Lead Institution
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Participating Centers
3 in China + 36 overseas
CDE Registry ID
CTR20261752
Internal Protocol ID
QLS4131-202
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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