Clinical Trials in China / NCT06049290
Recruiting
Phase 1/2
A Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma
NCT06049290 · tracked via the Priya Life Science China tracker
Condition(s) studied
Relapsed/Refractory Multiple Myeloma
Investigational drug(s) / intervention(s)
LBL-034 for Injection
LBL-034 for Injection: Q2W; intravenous infusion
Study summary
This trial is a single-arm, open-label, multicenter phase I/II clinical study of LBL-034 in patients with RRMM to evaluate the safety, tolerability, PK profile, immunogenicity and efficacy of LBL-034.
Eligibility
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,or according to the IMWG 2021 diagnostic criteria, the proportion of circulating plasma cells in peripheral blood is ≥ 5%,have documentation to diagnose PCL；
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 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.
Primary outcome measure(s)
- Objective Response Rate (ORR) — 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).
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 II study . - Dose-limiting toxicities（DLT） — 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).
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 . - Maximum tolerated dose (MTD) — 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).
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. - Occurrence of adverse event (AE) and serious adverse event (SAE) — From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-034 will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase I study.
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | Recruiting |
| Peking University People's Hospital | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | Recruiting |
| The Afliliated Hospital of Guizhou Medical Univeristy | Guiyang | Guizhou | Recruiting |
| The Second Affiliated Hospital of Hainan Medical University | Haikou | Hainan | Recruiting |
| The First Affiliated Hospital of Henan University | Luoyang | Henan | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Recruiting |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | Recruiting |
| The First Bethune Hospital of Jilin University | Changchun | Jilin | Recruiting |
| Shengjing Hospital of China Medical University | Shengyang | Liaoning | Recruiting |
| Qingdao Municipal Hospital | Qingdao | Shandong | Recruiting |
| Shanghai Fourth People's Hospital | Shanghai | Shanghai Municipality | Recruiting |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | Recruiting |
| The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital) | Xi’an | Shanxi | Recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | Recruiting |
| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | Recruiting |
More Nanjing Leads Biolabs Co.,Ltd trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06049290 on ClinicalTrials.gov ↗ ← All trials in China