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
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
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
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 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.
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.
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 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.
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.
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.
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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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