A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Interventions
- Drug: LBL-034 for Injection
- Registration Number
- NCT06049290
- Lead Sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Brief 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 R/R MM.
- Detailed Description
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 trial includes two parts: phase I and phase IIa study.
The dose escalation and dose expansion studies for LBL-034 will be conducted in the phase I study to evaluate safety, tolerability and determine RP2D.
The efficacy of LBL-034 in the treatment of R/R MM and R/R leukaemia plasmacytic (plasma cell leukemia, PCL) will be evaluated in Phase IIa study.Phase IIa clinical study will be conducted after obtaining the RP2D.Determine the specific dosing regimen in Phase IIa based on the safety, PK and other data from Phase I clinical studies.Phase IIa clinical study includes 4 cohorts.
This clinical trial will enroll 342 patients in Phase I and Phase IIa studies.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 342
- 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.
- Subjects who underwent major organ surgery (excluding needle biopsy) within 4 weeks prior to the initial use of the investigational drug,or significant trauma ,or require elective surgery during the trial period;
- 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；
- 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);
- Patients with active hepatitis B or C；
- Subjects with an active infection that currently requires intravenous anti infective therapy;
- History of immunodeficiency, including positive HIV antibody test results;
- Pregnant or lactating women;
- The investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LBL-034 LBL-034 for Injection LBL-034 for Injection; Initial dose - MTD; Q2W
- Primary Outcome Measures
Name Time Method 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 IIa study .
Dose-limiting toxicities（DLT） The DLT observation period starts from the first dose to 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. 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 to 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 of LBL-034 in Phase I study .
- Secondary Outcome Measures
Name Time Method Minimal Residual Disease (MRD) 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) MRD-negative rate: Refers to the percentage of subjects who achieve MRD negativity at any time point after the initial dose and before disease progression or the initiation of a new anti-tumor therapy.
Cmax 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) Maximum serum concentration
Tmax 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) After taking a single dose, Time to reach maximum plasma concentration
Immunogenicity 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) The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects
Duration of Response(DOR） 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) The period from the participants first achieving CR or PR to disease progression.
sBCMA 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) serum B-cell maturation antigen(Detect the change of sBCMA in serum)
Trial Locations
- Locations (20)
Shengjing Hospital of China Medical University
🇨🇳Shengyang, Liaoning, China
The First Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Peking University Shougang Hospital
🇨🇳Beijing, Beijing, 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 Zhejiang University School of Medicine
🇨🇳Hangzhou, Hangzhou, China
The First Affiliated Hospital of Henan University
🇨🇳Luoyang, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Institute of hematology & blood diseases hospital, chinese academy of medical sciences & peking union medical college
🇨🇳Tianjin, Tianjin, China
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
🇨🇳Xi'an, Xi'an, China
The First Affiliated Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China