GPRC5D × CD3 bispecific antibody · relapsed/refractory multiple myeloma Phase I/II clinical trial
Official protocol title:A Multicenter, Open-label, Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-034 in Patients with Relapsed/Refractory Multiple Myeloma
Trial Summary
This is a Phase I/II clinical trial sponsored by Nanjing Leads Biolabs Co., Ltd., primarily evaluating patients with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory plasma cell leukemia (RR PCL) (without strict restrictions on prior lines of therapy or specific gene mutations). The treatment regimen consists of monotherapy with an innovative biologic (LBL-034 for injection) administered by intravenous infusion at a dosing frequency of once every two weeks (Q2W). The study is being conducted at 21 renowned domestic hospitals in China, including Peking University People's Hospital, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital, Zhejiang University School of Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Sun Yat-sen University Cancer Center.
Participating Centers1 in China + 20 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
- CTR20232974
- Verify on the NMPA CDE public platformby entering CTR20232974 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 7 inclusion and 9 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 [GPRC5D × 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/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 1 study centres in China and 20 overseas centres. The lead institution is [Peking University People's Hospital]. Prominent sites include Peking University People's Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Qingdao Municipal Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20232974] (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/II
Target / Therapy
GPRC5D × CD3 bispecific antibody
Sponsor
Nanjing Leads Biolabs Co., Ltd.
Principal Investigator
Jin Lu
Lead Institution
Peking University People's Hospital
Participating Centers
1 in China + 20 overseas
CDE Registry ID
CTR20232974
ClinicalTrials.gov ID
NCT06049290Trial 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
Browse comparable active studies by disease stage, modality and province
Keywords
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.
View CAR-T in China Guide →Evidence · Process · Costs · Verified hospitals
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.
Read application guide & patient rights