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

April 15, 2024 updated by: Nanjing Leads Biolabs Co.,Ltd

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 II 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 treatment of R/R MM will be evaluated in the phase II study. Phase II study includes 2 arms.

This clinical trial will enroll 66-418 patients in Phase I and Phase II studies.

Study Type

Interventional

Enrollment (Estimated)

418

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Wuhu, Anhui, China, 241001
        • Recruiting
        • The first affiliated hospital of Wannan Medical College
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100044
      • Beijing, Beijing, China, 100144
        • Not yet recruiting
        • Peking University Shougang Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Xiamen, Fujian, China, 361000
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 516000
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Shenzhen, Guangdong, China, 518035
    • Guizhou
      • Guiyang, Guizhou, China, 563000
        • Not yet recruiting
        • The Afliliated Hospital of Guizhou Medical Univeristy
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570000
        • Not yet recruiting
        • The Second Affiliated Hospital of Hainan Medical University
        • Contact:
    • Hangzhou
      • Hangzhou, Hangzhou, China, 310000
        • Not yet recruiting
        • The First Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shengyang, Liaoning, China, 117004
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
    • Shandong
      • Qingdao, Shandong, China, 266011
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Not yet recruiting
        • Institute of hematology & blood diseases hospital, chinese academy of medical sciences & peking union medical college
        • Contact:
    • Xi'an
      • Xi'an, Xi'an, China, 710004
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
        • Contact:
    • Zhejiang
      • Ningbo, Zhejiang, China, 315000
        • Not yet recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject has voluntarily agreed to participate by giving written informed consent for the trial;
  2. Age ≥ 18 years on day of signing the Informed Consent Form;
  3. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
  4. Documented 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 corticosteroidsor 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. Central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM；
  5. Subjects with an active infection that currently requires intravenous anti infective therapy;
  6. History of immunodeficiency, including positive HIV antibody test results;
  7. Pregnant or lactating women;
  8. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBL-034
LBL-034 for Injection; Initial dose - MTD; Q2W
Drug: LBL-034 for Injection
Initial dose - MTD; Q2W; intravenous infusion
Other Names:
  • LBL-034

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 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, 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 .
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).
Dose-limiting toxicities（DLT）
Time Frame: 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 .
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).
Maximum tolerated dose (MTD)
Time Frame: 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 .
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 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
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)
Tmax
Time Frame: 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
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)
Immunogenicity
Time Frame: 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
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)
Minimal Residual Disease (MRD)
Time Frame: 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.
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)
Duration of Response(DOR）
Time Frame: 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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Leads Biolabs Co.,Ltd

Investigators

  • Principal Investigator: Jin Lu, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

May 20, 2027

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBL-034-CN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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