RecruitingPhase IICTR20261752Trispecific antibody targeting BCMA, CD3, and GPRC5D

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

Sponsor: Qilu Pharmaceutical Co., Ltd.Updated: 9/3/2026
Target CohortMultiple myeloma(Synthesized by CMDN from protocol summary; final eligibility confirmed by study doctors)

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

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
Heze Municipal Hospital
Tai'an City Central Hospital
Xuchang Central Hospital
Qingdao Municipal Hospital
Jining No. 1 People's Hospital
Third Xiangya Hospital of Central South University
The First Affiliated Hospital of Kunming Medical University
Chongqing University Cancer Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
Shanxi Provincial Cancer Hospital
Shaanxi Provincial People's Hospital
Sichuan Provincial People's Hospital
The First Affiliated Hospital of Anhui Medical University
The Second Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital, Zhejiang University School of Medicine
The First Affiliated Hospital of Wenzhou Medical University
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Zhongda Hospital Southeast University
Shanghai Fourth People's Hospital
The First Affiliated Hospital of Guangxi Medical University
Yulin Red Cross Hospital
The Second Affiliated Hospital of Nanchang University
Jiangxi Provincial People's Hospital
Zhujiang Hospital of Southern Medical University
Sun Yat-sen University Cancer Center
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
The Second Hospital of Hebei Medical University
Shengjing Hospital of China Medical University
The First Hospital of China Medical University
吉林大学第一医院
Peking University Third Hospital
The First Affiliated Hospital of Harbin Medical University
Weifang People's Hospital
Guizhou Provincial People's Hospital
The Second Affiliated Hospital of Hainan Medical University
The First Affiliated Hospital of Guilin Medical University

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

QWhich patient group is targeted by this clinical trial?

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.

QWhat are the specific eligibility criteria regarding age, performance status, and prior therapy?

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.

QWhat are the investigational targets and mechanism of action?

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.

QWhat clinical phase is this study in?

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.

QWhere are the participating hospital trial centers located?

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.

QWhat is the official trial registration code and how can it be verified?

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.

Note for International Patients: Trial centers for this study are located in China. Interventional trials strictly comply with domestic Human Genetic Resources (HGRAC) regulations and standard hospital protocols, which generally restrict enrollment to residents with domestic healthcare identification. International patients seeking approved cellular therapies should review commercial options.

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

NCT06500507

Trial 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

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Keywords

QLS4131 for injectionmalignant plasma cell neoplasmsplasma cell leukemiamultiple myelomaPhase II clinical trial

Considering a non-trial option?

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Patient Rights & Safety Assurance

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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