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

Relapsed/Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049290
• Other study ID #: LBL-034-CN001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 20, 2023
• Est. completion date: May 20, 2027

Study information

• Verified date: April 2024
• Source: Nanjing Leads Biolabs Co.,Ltd
• Contact: DongTao Meng
• Phone: 025-83378099
• Email: mengdongtao[@]leadsbiolabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 418
• Est. completion date: May 20, 2027
• Est. primary completion date: October 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma

Intervention

Drug:
• LBL-034 for Injection
Initial dose - MTD; Q2W; intravenous infusion

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Sun Yat-sen University Cancer Center	Guangzhou	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	The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Shengjing Hospital of China Medical University	Shengyang	Liaoning
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
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 First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui
China	The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)	Xi'an	Xi'an
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Leads Biolabs Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	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).
Primary	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 .	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).
Primary	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 .	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	Cmax	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)
Secondary	Tmax	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)
Secondary	Immunogenicity	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)
Secondary	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.	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)
Secondary	Duration of Response(DOR)	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)