search
Back to results

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

Primary Purpose

Relapsed/Refractory Multiple Myeloma

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
LBL-034 for Injection
Sponsored by
Nanjing Leads Biolabs Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject has voluntarily agreed to participate by giving written informed consent for the trial; Age ≥ 18 years on day of signing the Informed Consent Form; Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale; Documented 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. Exclusion Criteria: 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; 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 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); Central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM; 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.

Sites / Locations

  • The First Affiliated Hospital of Wannan Medical College
  • Peking University Shougang Hospital
  • Peking University People's Hospital
  • Shenzhen Second People's Hospital
  • The First Affiliated Hospital of Henan University
  • ShengJing Hospital Of China Medical University
  • Qingdao Municipal Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LBL-034

Arm Description

LBL-034 for Injection; Initial dose - MTD; Q2W

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
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 .
Dose-limiting toxicities(DLT)
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)
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

Cmax
Maximum serum concentration
Tmax
After taking a single dose, Time to reach maximum plasma concentration
Immunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects
Minimal Residual Disease (MRD)
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.
Duration of Response(DOR)
The period from the participants first achieving CR or PR to disease progression.

Full Information

First Posted
September 15, 2023
Last Updated
September 24, 2023
Sponsor
Nanjing Leads Biolabs Co.,Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT06049290
Brief Title
A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 16, 2023 (Anticipated)
Primary Completion Date
October 20, 2026 (Anticipated)
Study Completion Date
May 20, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Leads Biolabs Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
418 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LBL-034
Arm Type
Experimental
Arm Description
LBL-034 for Injection; Initial dose - MTD; Q2W
Intervention Type
Drug
Intervention Name(s)
LBL-034 for Injection
Other Intervention Name(s)
LBL-034
Intervention Description
Initial dose - MTD; Q2W; intravenous infusion
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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 .
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).
Title
Dose-limiting toxicities(DLT)
Description
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 .
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).
Title
Maximum tolerated dose (MTD)
Description
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 .
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).
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum serum concentration
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)
Title
Tmax
Description
After taking a single dose, Time to reach maximum plasma concentration
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)
Title
Immunogenicity
Description
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects
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)
Title
Minimal Residual Disease (MRD)
Description
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.
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)
Title
Duration of Response(DOR)
Description
The period from the participants first achieving CR or PR to disease progression.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has voluntarily agreed to participate by giving written informed consent for the trial; Age ≥ 18 years on day of signing the Informed Consent Form; Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale; Documented 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. Exclusion Criteria: 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; 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 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); Central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DongTao Meng
Phone
025-83378099
Email
mengdongtao@leadsbiolabs.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Lu
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
241001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DongTao Meng
Phone
02583378099
Email
mengdongtao@leadsbiolabs.com
Facility Name
Peking University Shougang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100041
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DongTao Meng
Phone
02583378099
Email
mengdongtao@leadsbiolabs.com
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DongTao Meng
Phone
02583378099
Email
mengdongtao@leadsbiolabs.com
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DongTao Meng
Phone
02583378099
Email
mengdongtao@leadsbiolabs.com
Facility Name
The First Affiliated Hospital of Henan University
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DongTao Meng
Phone
02583378099
Email
mengdongtao@leadsbiolabs.com
Facility Name
ShengJing Hospital Of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DongTao Meng
Phone
02583378099
Email
mengdongtao@leadsbiolabs.com
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266011
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DongTao Meng
Phone
02583378099
Email
mengdongtao@leadsbiolabs.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs