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Taking people in ChinaPhase 1/2

Tests LBL-034 in adults with relapsed or refractory multiple myeloma

Tests the drug LBL-034 in adults whose multiple myeloma has returned or stopped responding.

Key facts

Who runs it
Nanjing Leads Biolabs Co.,Ltd
Where
Beijing, Changchun, Guangzhou, Guiyang, Haikou, Hangzhou, Luoyang, Ningbo, Qingdao, Shanghai, Shengyang, Shenzhen, Suzhou, Taiyuan, Wenzhou, Wuhan, Wuhu, Xi'an, Xiamen, and Zhengzhou, ChinaSee the 21 sites
Trial code
Registry title
A Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma
Status
Recruiting
Phase
Phase 1/2
People taking part
342 people, planned
Started
20 Oct 2023
Expected to end
20 Sept 2029
Type of study
Interventional
Treatments tested
  • LBL-034 for Injection
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with multiple myeloma that came back or did not respond to earlier treatment, to test the drug LBL-034.

Age
18 years or older
Sex
All sexes
Disease stage
Multiple myeloma, diagnosed by IMWG criteria, that has relapsed or is refractory (relapsed/refractory). Plasma cell leukemia (PCL) can also be documented.
Earlier treatment
Cannot join if they used immune-modulating drugs (such as thymosin, interleukin-2, interferon) or systemic corticosteroids or other immunosuppressants within 14 days before the first dose.

Main reasons for not taking part

  • Major organ surgery or significant trauma within 4 weeks before the first dose, or planned surgery during the trial
  • Active hepatitis B or C
  • Active infection that needs treatment against infection
  • History of immunodeficiency, including HIV antibody positive
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form
  • Age ≥ 18 years at the time of signing the informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Scale≤ 1；
  • Documentation of initial diagnosis of multiple myeloma according to IMWG diagnostic criteria,or according to the IMWG 2021 diagnostic criteria, the proportion of circulating plasma cells in peripheral blood is ≥ 5%,have documentation to diagnose PCL；
  • Have a life expectancy of at least 12 weeks；
  • Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug

Who cannot take part

  • Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug,or require elective surgery during the trial period
  • Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin-2, and interferon；
  • Systemic use of corticosteroids or other immunosuppressants within 14 days prior to the initial use of the investigational drug;The following conditions are excluded: Treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of glucocorticoids for preventive therapy (e.g., to prevent contrast allergy)
  • Patients with active hepatitis B or C；
  • Subjects with an active infection that currently requires anti infective therapy
  • The patient has a Medical history of immunodeficiency, including HIV antibody positive
  • The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study
  • Women during pregnancy or lactation

Where in China

  • Peking University People's HospitalBeijing, ChinaContact: DongTao MengTaking people
  • The First Bethune Hospital of Jilin UniversityChangchun, ChinaContact: DongTao MengTaking people
  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: DongTao MengTaking people
  • The Afliliated Hospital of Guizhou Medical UniveristyGuiyang, ChinaContact: DongTao MengTaking people
  • The Second Affiliated Hospital of Hainan Medical UniversityHaikou, ChinaContact: DongTao MengTaking people
  • The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaContact: DongTao MengTaking people
  • The First Affiliated Hospital of Henan UniversityLuoyang, ChinaContact: DongTao MengTaking people
  • The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaContact: DongTao MengTaking people
  • QingDao Municipal HospitalQingdao, ChinaContact: DongTao MengTaking people
  • Shanghai Fourth People's HospitalShanghai, ChinaContact: dongtao mengTaking people
  • Shengjing Hospital of China Medical UniversityShengyang, ChinaContact: DongTao MengTaking people
  • Shenzhen Second People's HospitalShenzhen, ChinaContact: DongTao MengTaking people
  • The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaContact: dongtao mengTaking people
  • Shanxi Bethune HospitalTaiyuan, ChinaContact: DongTao MengTaking people
  • The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaContact: DongTao MengTaking people
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: DongTao MengTaking people
  • The First Affiliated Hospital of Wannan Medical CollegeWuhu, ChinaContact: DongTao MengTaking people
  • The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital)Xi'an, ChinaContact: DongTao MengTaking people
  • The First Affiliated hospital of Xiamen UniversityXiamen, ChinaContact: DongTao MengTaking people
  • Henan Cancer HospitalZhengzhou, ChinaContact: dongtao mengTaking people
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaContact: dongtao mengTaking people

About the trial

What the trial wants to find out

This trial is a single-arm, open-label, multicenter phase I/II clinical study of LBL-034 in patients with RRMM to evaluate the safety, tolerability, PK profile, immunogenicity and efficacy of LBL-034.

The group in the trial

  • LBL-034Treatment being tested

    LBL-034 for Injection; Q2W

    Treatment: LBL-034 for Injection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests LBL-034 in adults with relapsed or refractory multiple myelomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 November 2026