Relapsed/Refractory Multiple MyelomaPhase 1/2NCT06049290

A Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma

A Phase 1/2 study testing LBL-034 for Injection in people with Relapsed/Refractory Multiple Myeloma, run by Nanjing Leads Biolabs Co.,Ltd at 21 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed/Refractory Multiple Myeloma
What is being tested?: LBL-034 for Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 342 participants
Where: 21 sitesChina
Study dates: 20 Oct 2023to 20 May 2027
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 join

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;
Women during pregnancy or lactation;
The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

jin lu contact

025-83378099

mengdongtao@leadsbiolabs.com

City, postcode or hospital

Sites recruiting now only

21 sites in 1 country

China21 sites, 21 recruiting

Peking University People's Hospital
Beijing, Beijing Municipality, 100044
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130000
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 516000
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The Afliliated Hospital of Guizhou Medical Univeristy
Guiyang, Guizhou, 563000
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570000
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The First Affiliated Hospital of Henan University
Luoyang, Henan, 471003
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong, 266011
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, 200000
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
Recruiting
Shengjing Hospital of China Medical University
Shengyang, Liaoning, 117004
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, 710004
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
DongTao Meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
dongtao meng, 02583378099, mengdongtao@leadsbiolabs.com
Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
Recruiting

Other trials in China

About this study

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

Read the detailed description

This trial includes two parts: Phase I study and Phase II 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. In the dose escalation phase, the DLT observation period is from the first dose to 4 weeks after the prescribed dose is administered.Dose expansion or study at different dosing intervals in the expected effective dose group will be judged by the investigator and the sponsor based on the dose escalation data of LBL-034.

The efficacy of LBL-034 in the treatment of RRMM and RR PCL(plasma cell leukemia, PCL) will be assessed in Phase II study.

Phase II clinical study will be conducted after obtaining the RP2D.Determine the specific dosing regimen in Phase II based on the safety, PK and other data from Phase I clinical studies.Phase II 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 II studies.

Conditions: Relapsed/Refractory Multiple Myeloma
Being tested: LBL-034 for Injection
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LBL-034 for InjectionDrug
Also called LBL-034
Q2W; intravenous infusion

Study groups in NCT06049290
Study group	Role	What they receive
LBL-034	Experimental	LBL-034 for Injection; Q2W Receives: Drug: LBL-034 for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR)
ORR [including the rates of Strin-gent complete response(sCR),complete response (CR) ,Very good partial response(VGPR),and partial response (PR)], evaluated based on the 2016 IMWG criteria(Cohorts 1, 2, and 3) and 2013 IMWG criteria(Cohort 4), refers to the percentage of study subjects who achieve a complete response or partial response. It was used to evaluate the efficacy of LBL-034 in Phase II study .
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy).
Dose-limiting toxicities（DLT）
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.DLT is defined as toxicity (possible adverse events related to LBL-034) during the DLT observation period . It was used to evaluate the safety of LBL-034 in Phase I study .
Measured: The DLT observation period starts from the first dose until 4 weeks after the full dose first administration (including the step-up dosing period, if any).
Maximum tolerated dose (MTD)
MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles. It was used to evaluate the tolerability in Phase I.
Measured: The MTD observation period starts from the first dose until 4 weeks after the full dose first administration (including the step-up dosing period, if any).
Occurrence of adverse event (AE) and serious adverse event (SAE)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-034 will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase I study.
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)

Secondary outcomes (6)

Cmax
Maximum drug concentration in plasma after administration.
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
Tmax
After administration,Time to reach maximum drug concentration in plasma.
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
Immunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response.
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
Minimal Residual Disease (MRD)
MRD-negative rate: Refers to the percentage of subjects who achieve MRD negativity at any time point after the initial dose and before disease progression or the initiation of a new anti-tumor therapy.
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
Duration of Response(DOR）
DOR is defined as the duration from earliest date of disease response (CR、PR 、iCR or iPR) until earliest date of disease progression or death from any cause(if occurring sooner than progression).
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
sBCMA
serum B-cell maturation antigen(Detect the change of sBCMA in serum)
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 202320 May 2027

First posted22 Sep 2023
Study start20 Oct 2023
Primary completion20 Oct 2026 (estimated)
Study completion20 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Nanjing Leads Biolabs Co.,LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 342 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06049290
Sponsor's protocol ID: LBL-034-CN001
Status last verified: Sep 2026
First submitted: 15 Sep 2023
Last updated: 11 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06049290
Acronym / sponsor ID: LBL-034-CN001
Conditions: Relapsed/Refractory Multiple Myeloma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 342 participants (estimated)
Lead sponsor: Nanjing Leads Biolabs Co.,LtdIndustry (pharma, biotech, devices)
Study start: 20 Oct 2023 (actual)
Primary completion: 20 Oct 2026 (estimated)
Study completion: 20 May 2027 (estimated)
First posted: 22 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This trial includes two parts: Phase I study and Phase II study.

The efficacy of LBL-034 in the treatment of RRMM and RR PCL(plasma cell leukemia, PCL) will be assessed in Phase II study.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LBL-034	Experimental	Drug: LBL-034 for InjectionLBL-034 for Injection; Q2W

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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；

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LBL-034 for InjectionAlso: LBL-034Q2W; intravenous infusion	Drug	LBL-034

Primary outcome

Objective Response Rate (ORR)
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy).
ORR [including the rates of Strin-gent complete response(sCR),complete response (CR) ,Very good partial response(VGPR),and partial response (PR)], evaluated based on the 2016 IMWG criteria(Cohorts 1, 2, and 3) and 2013 IMWG criteria(Cohort 4), refers to the percentage of study subjects who achieve a complete response or partial response. It was used to evaluate the efficacy of LBL-034 in Phase II study .
Dose-limiting toxicities（DLT）
Time frame: The DLT observation period starts from the first dose until 4 weeks after the full dose first administration (including the step-up dosing period, if any).
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.DLT is defined as toxicity (possible adverse events related to LBL-034) during the DLT observation period . It was used to evaluate the safety of LBL-034 in Phase I study .
Maximum tolerated dose (MTD)
Time frame: The MTD observation period starts from the first dose until 4 weeks after the full dose first administration (including the step-up dosing period, if any).
MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles. It was used to evaluate the tolerability in Phase I.
Occurrence of adverse event (AE) and serious adverse event (SAE)
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-034 will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase I study.

6 secondary outcomes

Cmax
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
Tmax
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
Immunogenicity
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
Minimal Residual Disease (MRD)
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
Duration of Response(DOR）
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
sBCMA
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

jin lu contact

025-83378099

mengdongtao@leadsbiolabs.com

Jin Lu principal investigator

Peking University People's Hospital

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LBL-034 for Injection in people with Relapsed/Refractory Multiple Myeloma, run by Nanjing Leads Biolabs Co.,Ltd at 21 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact jin lu (025-83378099, mengdongtao@leadsbiolabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06049290.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.