RecruitingPhase 1Phase 2NCT06049290

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

Sponsor

Nanjing Leads Biolabs Co.,Ltd

Enrollment

342 participants

Start Date

Oct 20, 2023

Study Type

INTERVENTIONAL

Conditions

Relapsed/Refractory Multiple Myeloma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial tests a new drug called LBL-034 in patients with multiple myeloma (a blood cancer) that has come back or stopped responding to previous treatments. The goal is to assess how safe the drug is and whether it works. **You may be eligible if...** - You are 18 or older - You have been diagnosed with multiple myeloma that has relapsed or is no longer responding to treatment - You are in reasonably good overall health (able to care for yourself) - You have a life expectancy of at least 12 weeks - You are willing to use effective contraception during and after the study **You may NOT be eligible if...** - You had major surgery in the past 4 weeks - You have been on immune-boosting drugs or corticosteroids recently - You have active hepatitis B or C, or an active infection needing IV antibiotics - You are HIV-positive, pregnant, or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLBL-034 for Injection

Initial dose - MTD; Q2W; intravenous infusion

Locations(26)

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Peking University Shougang Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

The Afliliated Hospital of Guizhou Medical Univeristy

Guiyang, Guizhou, China

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

The First Affiliated Hospital of Henan University

Luoyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shengyang, Liaoning, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

Shanghai Fourth People's Hospital

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)

Xi’an, Shanxi, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

Institute of hematology & blood diseases hospital, chinese academy of medical sciences & peking union medical college

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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