A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma

Last updated: December 3, 2025
Sponsor: Nanjing Leads Biolabs Co.,Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Multiple Myeloma

Bone Diseases

Bone Neoplasm

Treatment

LBL-034 for Injection

Clinical Study ID

NCT06049290
LBL-034-CN001
  • Ages > 18
  • All Genders

Study Summary

This is a single-arm, open-label, multicenter, dose-escalation, and dose-expansion phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and efficacy of LBL-034 in patients with Relapsed/Refractory Multiple Myeloma (R/R MM).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Agree to follow the trial treatment regimen and visit schedule, voluntarily enrollin the study, and sign the written informed consent form;

  2. Age ≥ 18 years at the time of signing the informed consent;

  3. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale≤ 1;

  4. Documentation of initial diagnosis of multiple myeloma according to IMWG diagnosticcriteria;

  5. Have a life expectancy of at least 12 weeks;

  6. Fertile men and women of childbearing age are willing to take effectivecontraceptive measures (including abstinence, intrauterine devices, hormonalcontraception, and correct use of condoms) from the signing of the informed consentform to 6 months after the last dose of the investigational drug; women ofchildbearing age include premenopausal women and women who had menopause less thantwo years ago. Blood pregnancy test results must be negative for women ofchildbearing age within 7 days prior to the initial dose of the investigationaldrug.

Exclusion

Exclusion Criteria:

  1. Subjects who underwent major organ surgery (excluding needle biopsy) or significanttrauma within 4 weeks prior to the initial use of the investigational drug,orrequire elective surgery during the trial period;

  2. Use of immunomodulatory drugs within 14 days prior to the initial use of theinvestigational drug, including but not limited to thymosin, interleukin-2, andinterferon;

  3. Systemic use of corticosteroids or other immunosuppressants within 14 days prior tothe initial use of the investigational drug;The following conditions are excluded:Treatment with topical, ocular, intra-articular, intranasal, and inhaledcorticosteroids; short-term use of glucocorticoids for preventive therapy (e.g., toprevent contrast allergy);

  4. Patients with active hepatitis B or C;

  5. Subjects with an active infection that currently requires intravenous anti infectivetherapy;

  6. The patient has a Medical history of immunodeficiency, including HIV antibodypositive;

  7. Women during pregnancy or lactation;

  8. The investigator believes that the subject has other conditions that may affectcompliance or are not suitable for participating in this study.

Study Design

Total Participants: 342
Treatment Group(s): 1
Primary Treatment: LBL-034 for Injection
Phase: 1/2
Study Start date:
October 20, 2023
Estimated Completion Date:
May 20, 2027

Study Description

A multicenter, open-label, phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of LBL-034 in patients with relapsed/refractory multiple myeloma.

This trial includes two parts: phase I and phase IIa study.

The dose escalation and dose expansion studies for LBL-034 will be conducted in the phase I study to evaluate safety, tolerability and determine RP2D.

The efficacy of LBL-034 in the treatment of R/R MM and R/R leukaemia plasmacytic (plasma cell leukemia, PCL) will be evaluated in Phase IIa study.Phase IIa clinical study will be conducted after obtaining the RP2D.Determine the specific dosing regimen in Phase IIa based on the safety, PK and other data from Phase I clinical studies.Phase IIa clinical study includes 4 cohorts.This trial requires collection of biological samples from all subjects for relevant testing.

This clinical trial will enroll 342 patients in Phase I and Phase IIa studies.

Connect with a study center

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui 241001
    China

    Site Not Available

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu 1791236, Anhui 1818058 241001
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Peking University Shougang Hospital

    Beijing, Beijing 100144
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing 1816670, Beijing Municipality 2038349 100044
    China

    Active - Recruiting

  • Peking University Shougang Hospital

    Beijing 1816670, Beijing Municipality 2038349 100144
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350000
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361000
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou 1810821, Fujian 1811017 350000
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen 1790645, Fujian 1811017 361000
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 516000
    China

    Site Not Available

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong 518035
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou 1809858, Guangdong 1809935 516000
    China

    Active - Recruiting

  • Shenzhen Second People's Hospital

    Shenzhen 1795565, Guangdong 1809935 518035
    China

    Active - Recruiting

  • The Afliliated Hospital of Guizhou Medical Univeristy

    Guiyang, Guizhou 563000
    China

    Site Not Available

  • The Afliliated Hospital of Guizhou Medical Univeristy

    Guiyang 1809461, Guizhou 1809445 563000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan 570000
    China

    Site Not Available

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou 1809078, Hainan 1809054 570000
    China

    Active - Recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Hangzhou 310000
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University

    Luoyang, Henan 471003
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University

    Luoyang 1801792, Henan 1808520 471003
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou 1784658, Henan 1808520 450008
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658, Henan 1808520 450052
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949 430000
    China

    Active - Recruiting

  • Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 410008
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou 1886760, Jiangsu 1806260 215006
    China

    Site Not Available

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin 130000
    China

    Site Not Available

  • The First Bethune Hospital of Jilin University

    Changchun 2038180, Jilin 2036500 130000
    China

    Active - Recruiting

  • ShengJing Hospital Of China Medical University

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shengyang, Liaoning 2036115 117004
    China

    Active - Recruiting

  • Qingdao Municipal Hospital

    Qingdao, Shandong 266011
    China

    Site Not Available

  • Qingdao Municipal Hospital

    Qingdao 1797929, Shandong 1796328 266011
    China

    Active - Recruiting

  • Shanghai Fourth People's Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200000
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030000
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan 1793511, Shanxi 1795912 030000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi’an 11474004, Shanxi 1795912 710061
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)

    Xi’an 11474004, Shanxi 1795912 710004
    China

    Active - Recruiting

  • Institute of hematology & blood diseases hospital, chinese academy of medical sciences & peking union medical college

    Tianjin, Tianjin 300000
    China

    Site Not Available

  • Institute of hematology & blood diseases hospital, chinese academy of medical sciences & peking union medical college

    Tianjin 1792947, Tianjin Municipality 1792943 300000
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)

    Xi'an, Xi'an 710004
    China

    Site Not Available

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 315000
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo 1799397, Zhejiang 1784764 315000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388, Zhejiang 1784764 325000
    China

    Active - Recruiting

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