A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma
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
1 other identifier
interventional
342
1 country
26
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2023
Typical duration for phase_1
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2023
CompletedFirst Posted
Study publicly available on registry
September 22, 2023
CompletedStudy Start
First participant enrolled
October 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 20, 2027
December 4, 2025
May 1, 2025
3 years
September 15, 2023
December 3, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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 IIa study .
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 .
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.
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).
Secondary Outcomes (6)
Cmax
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
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
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)
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）
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)
- +1 more secondary outcomes
Study Arms (1)
LBL-034
EXPERIMENTALLBL-034 for Injection; Initial dose - MTD; Q2W
Interventions
Eligibility Criteria
You may qualify if:
- 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；
- 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.
You may not qualify if:
- 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 intravenous 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 516000, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
The Afliliated Hospital of Guizhou Medical Univeristy
Guiyang, Guizhou, 563000, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570000, China
The First Affiliated Hospital of Henan University
Luoyang, Henan, 471003, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130000, China
Shengjing Hospital of China Medical University
Shengyang, Liaoning, 117004, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266011, China
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, 200000, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000, China
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, 710004, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061, China
Institute of hematology & blood diseases hospital, chinese academy of medical sciences & peking union medical college
Tianjin, Tianjin Municipality, 300000, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Lu
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2023
First Posted
September 22, 2023
Study Start
October 20, 2023
Primary Completion (Estimated)
October 20, 2026
Study Completion (Estimated)
May 20, 2027
Last Updated
December 4, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share