Actively Recruiting
A Multicenter, Open-label, Phase I/II Study to Evaluate Safety, Tolerability, and Efficacy of LBL-034 in Patients With Relapsed/Refractory Multiple Myeloma
Led by Nanjing Leads Biolabs Co.,Ltd · Updated on 2025-12-04
342
Participants Needed
26
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase I/II clinical study to assess the safety, tolerability, pharmacokinetics, immunogenicity, and effectiveness of LBL-034 in patients with relapsed or refractory multiple myeloma, including plasma cell leukemia. The study includes a dose-escalation phase to find the recommended dose and a dose-expansion phase to evaluate treatment effects. The trial is open-label and involves multiple centers. The treatment involves intravenous infusions of LBL-034 at an initial dose defined as the maximum tolerated dose (MTD), given every two weeks. The study has two parts: the phase I dose escalation and expansion to assess safety and dosage, followed by phase IIa which evaluates efficacy in four patient cohorts. Biological samples will be collected from all participants for testing. Participants will undergo various assessments including monitoring for objective response rate, dose-limiting toxicities, and maximum tolerated dose during treatment and up to 30 days after stopping the drug. Additional evaluations include drug concentration levels, immunogenicity, minimal residual disease, and duration of response. The total trial duration extends until May 2027, with patients followed closely throughout treatment and after drug withdrawal.
CONDITIONS
Brief Title
A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to follow the trial treatment and visit schedule and sign informed consent
- Age 18 years or older at consent
- ECOG performance status score of 0 or 1
- Documented initial diagnosis of multiple myeloma per IMWG criteria
- Life expectancy of at least 12 weeks
- Fertile men and women of childbearing age agree to effective contraception from consent until 6 months after last dose; women must have a negative pregnancy test within 7 days before first dose
You will not qualify if you...
- Major organ surgery or significant trauma within 4 weeks before first dose, or planned surgery during the trial
- Use of immunomodulatory drugs within 14 days before first dose
- Systemic corticosteroids or immunosuppressants within 14 days before first dose (excluding certain topical or short-term uses)
- Active hepatitis B or C infection
- Active infection requiring intravenous antibiotics
- History of immunodeficiency including HIV positive status
- Pregnant or breastfeeding women
- Conditions affecting compliance or suitability as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 6 months, depending on response and tolerability
Participants receive LBL-034 by intravenous infusion every two weeks to evaluate safety, tolerability, and efficacy.
Biweekly visits for intravenous infusions
Duration - 30 days after treatment ends
Participants are monitored for safety and response for 30 days after drug withdrawal or before starting new anti-tumor therapy.
1 to 2 visits during follow-up
Trial Site Locations
Total: 26 locations
1
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China, 241001
Actively Recruiting
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
3
Peking University Shougang Hospital
Beijing, Beijing Municipality, China, 100144
Not Yet Recruiting
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000
Not Yet Recruiting
5
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361000
Actively Recruiting
6
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 516000
Actively Recruiting
7
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China, 518035
Actively Recruiting
8
The Afliliated Hospital of Guizhou Medical Univeristy
Guiyang, Guizhou, China, 563000
Actively Recruiting
9
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China, 570000
Actively Recruiting
10
The First Affiliated Hospital of Henan University
Luoyang, Henan, China, 471003
Actively Recruiting
11
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
12
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
13
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
14
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
15
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Not Yet Recruiting
16
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
17
Shengjing Hospital of China Medical University
Shengyang, Liaoning, China, 117004
Actively Recruiting
18
Qingdao Municipal Hospital
Qingdao, Shandong, China, 266011
Actively Recruiting
19
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
20
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
21
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, China, 710004
Actively Recruiting
22
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
23
Institute of hematology & blood diseases hospital, chinese academy of medical sciences & peking union medical college
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
24
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
25
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315000
Actively Recruiting
26
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
J
jin lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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