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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Peking University Shougang Hospital
NOT_YET_RECRUITING
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The Afliliated Hospital of Guizhou Medical Univeristy
RECRUITING
Guiyang
The Second Affiliated Hospital of Hainan Medical University
RECRUITING
Haikou
The First Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital of Henan University
RECRUITING
Luoyang
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Qingdao Municipal Hospital
RECRUITING
Qingdao
Shengjing Hospital of China Medical University
RECRUITING
Shengyang
Shenzhen Second People's Hospital
RECRUITING
Shenzhen
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Institute of hematology & blood diseases hospital, chinese academy of medical sciences & peking union medical college
NOT_YET_RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Wannan Medical College
RECRUITING
Wuhu
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Contact Information
Primary
DongTao Meng
mengdongtao@leadsbiolabs.com
025-83378099
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2027-05-20
Participants
Target number of participants: 342
Treatments
Experimental: LBL-034
LBL-034 for Injection; Initial dose - MTD; Q2W
Related Therapeutic Areas
Sponsors
Leads: Nanjing Leads Biolabs Co.,Ltd

This content was sourced from clinicaltrials.gov

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