Testing LBL-034 for 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

This study is testing a new treatment called LBL-034 to see if it can help people with relapsed or refractory multiple myeloma feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 342 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (Industry-sponsored)
• Locations: 26 sites (Wuhu, Anhui and 25 other locations)
• Trial ID: NCT06049290 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of LBL-034 in patients with relapsed/refractory multiple myeloma. It consists of two parts: a phase I dose-escalation study to determine the recommended phase II dose (RP2D) and a phase IIa study to assess the efficacy of LBL-034 in treating the condition. The trial aims to enroll 342 patients and will include various cohorts in the phase IIa study based on data from the phase I study.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a documented diagnosis of relapsed/refractory multiple myeloma and an ECOG performance status of 1 or lower.

Not a fit: Patients with a life expectancy of less than 12 weeks or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed refractory multiple myeloma.

How similar studies have performed: Other studies have shown promise in using similar approaches for treating multiple myeloma, but this specific treatment is being evaluated for the first time.

Eligibility criteria

Inclusion Criteria:

1. Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form;
2. Age ≥ 18 years at the time of signing the informed consent;
3. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale≤ 1；
4. Documentation of initial diagnosis of multiple myeloma according to IMWG diagnostic criteria；
5. Have a life expectancy of at least 12 weeks；
6. 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.

Exclusion Criteria:

1. 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;
2. 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；
3. 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);
4. Patients with active hepatitis B or C；
5. Subjects with an active infection that currently requires intravenous anti infective therapy;
6. The patient has a Medical history of immunodeficiency, including HIV antibody positive;
7. Women during pregnancy or lactation;
8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Where this trial is running

Wuhu, Anhui and 25 other locations

• The First Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University Shougang Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (Recruiting)
• The Afliliated Hospital of Guizhou Medical Univeristy — Guiyang, Guizhou, China (Recruiting)
• The Second Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (Recruiting)
• The First Affiliated Hospital of Henan University — Luoyang, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Shengjing Hospital of China Medical University — Shengyang, Liaoning, China (Recruiting)
• Qingdao Municipal Hospital — Qingdao, Shandong, China (Recruiting)
• Shanghai Fourth People's Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)
• The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital) — Xi’an, Shanxi, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi’an, Shanxi, China (Not_yet_recruiting)
• Institute of hematology & blood diseases hospital, chinese academy of medical sciences & peking union medical college — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Jin Lu — Peking University People's Hospital
• Study coordinator: jin lu

Conditions Relapsed/Refractory Multiple Myeloma