A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma

NCT06049290
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
342
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Lead sponsor
Nanjing Leads Biolabs Co.,Ltd
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Start date
2023-10-20
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Number of sites
26
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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).
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Short title
A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma
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Official title
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2027-05-20
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First posted
2023-09-22
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Registry last updated
2025-12-04
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Primary completion date
2026-10-20
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Start date
2023-10-20
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Participants
342
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Participant count basis
Estimated
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Planned participants
342
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Protocol amendments
3
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Number of sites
26
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Nanjing Leads Biolabs Co.,Ltd
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06049290
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ClinicalTrials.gov ID
NCT06049290
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Objective Response Rate (ORR)

    Timeframe: 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 .

  2. Dose-limiting toxicities（DLT）

    Timeframe: 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 .

  3. Maximum tolerated dose (MTD)

    Timeframe: 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.

  1. Cmax

    Timeframe: 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 drug concentration in plasma after administration.

  2. Tmax

    Timeframe: 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 administration,Time to reach maximum drug concentration in plasma.

  3. Immunogenicity

    Timeframe: 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.Immunogenicity refers to the performance that can elicit an immune response.

  4. Minimal Residual Disease (MRD)

    Timeframe: 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.

  5. Duration of Response(DOR）

    Timeframe: 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)

    DOR is defined as the duration from earliest date of disease response (CR、PR 、iCR or iPR) until earliest date of disease progression or death from any cause(if occurring sooner than progression).

  6. sBCMA

    Timeframe: 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)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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.
Sources for eligibility
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  • The First Affiliated Hospital of Wannan Medical CollegeWuhu, ChinaRecruiting
  • Peking University People's HospitalBeijing, ChinaRecruiting
  • Peking University Shougang HospitalBeijing, ChinaNot yet recruiting
  • Fujian Medical University Union HospitalFuzhou, ChinaNot yet recruiting
  • The First Affiliated Hospital of Xiamen UniversityXiamen, ChinaRecruiting
  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting
  • Shenzhen Second People's HospitalShenzhen, ChinaRecruiting
  • The Afliliated Hospital of Guizhou Medical UniveristyGuiyang, ChinaRecruiting
  • The Second Affiliated Hospital of Hainan Medical UniversityHaikou, ChinaRecruiting
  • The First Affiliated Hospital of Henan UniversityLuoyang, ChinaRecruiting
  • Henan Cancer HospitalZhengzhou, ChinaNot yet recruiting
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaNot yet recruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologyWuhan, ChinaRecruiting
  • Xiangya Hospital of Central South UniversityChangsha, ChinaNot yet recruiting
  • The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaNot yet recruiting
  • The First Bethune Hospital of Jilin UniversityChangchun, ChinaRecruiting
  • Shengjing Hospital of China Medical UniversityShengyang, ChinaRecruiting
  • Qingdao Municipal HospitalQingdao, ChinaRecruiting
  • Shanghai Fourth People's HospitalShanghai, ChinaNot yet recruiting
  • Shanxi Bethune HospitalTaiyuan, ChinaRecruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)Xi’an, ChinaRecruiting
  • The First Affiliated Hospital of Xi'an Jiao Tong UniversityXi’an, ChinaNot yet recruiting
  • Institute of hematology & blood diseases hospital, chinese academy of medical sciences & peking union medical collegeTianjin, ChinaNot yet recruiting
  • The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaRecruiting
  • The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaRecruiting

And 1 more, listed on the interactive page.

Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)