RecruitingPhase ICTR20262569LILRB4 and CD3 bispecific antibody

LILRB4 and CD3 bispecific antibody · relapsed/refractory multiple myeloma Phase I clinical trial

Official protocol title:A Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of 6MW5311 in Patients with Relapsed/Refractory Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, and Multiple Myeloma

Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.Updated: 9/3/2026
Target CohortRelapsed/refractory(Synthesized by CMDN from protocol summary; final eligibility confirmed by study doctors)

Trial Summary

This clinical study aims to evaluate the safety, tolerability, and preliminary efficacy of 6MW5311 for injection in patients with hematologic malignancies. The target population consists of adult patients with relapsed/refractory acute myeloid leukemia, chronic myelomonocytic leukemia, and multiple myeloma. The trial is a single-arm, open-label Phase I dose-escalation and expansion study, in which participants will receive weekly injections of the investigational drug. This study is being conducted at multiple clinical centers in China, including Ruijin Hospital, Shanghai Jiao Tong University School of Medicine and Henan Cancer Hospital.

Participating Centers1 in China + 7 overseas

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Henan Cancer Hospital
The First Affiliated Hospital, Zhejiang University School of Medicine
Shengjing Hospital of China Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First Affiliated Hospital of Guangxi Medical University
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Chongqing 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
CTR20262569
Verify on the NMPA CDE public platformby entering CTR20262569 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 [Relapsed/refractory]. 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 ≤ 2, ≥ 3 prior lines of therapy. The study specifies 7 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 [LILRB4 and 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.

QWhat clinical phase is this study in?

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.

QWhere are the participating hospital trial centers located?

This is an international multi-centre study with 1 study centres in China and 7 overseas centres. The lead institution is [Ruijin Hospital, Shanghai Jiao Tong University School of Medicine]. Prominent sites include Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Henan Cancer Hospital, The First Affiliated Hospital, Zhejiang University School of Medicine, 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 [CTR20262569] (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 I

Target / Therapy

LILRB4 and CD3 bispecific antibody

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Principal Investigator

Jianqing Mi

Lead Institution

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Participating Centers

1 in China + 7 overseas

CDE Registry ID

CTR20262569

Internal Protocol ID

6MW5311-CP101

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

6MW5311hematologic malignanciesacute myeloid leukemiachronic myelomonocytic leukemiamultiple myeloma

Considering a non-trial option?

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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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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