Clinical trial NCT06049290: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Relapsed/Refractory Multiple Myeloma
Lead sponsor: Nanjing Leads Biolabs Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-22
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Relapsed/Refractory Multiple Myeloma (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 trial requires collection of biological samples from all subjects for relevant testing.

This clinical trial will enroll 342 patients in Phase I and Phase IIa studies.

Eligibility criteria: Inclusion Criteria:

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.

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 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.

Primary outcomes:
measure: 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).
measure: 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).
measure: 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).
Secondary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Guiyang
country: China
facility: The Afliliated Hospital of Guizhou Medical Univeristy
state: Guizhou
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
state: Hainan
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University School of Medicine
state: Hangzhou
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Shengyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Tianjin
country: China
facility: Institute of hematology & blood diseases hospital, chinese academy of medical sciences & peking union medical college
state: Tianjin
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
state: Xi'an
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Peking University People's Hospital
name: Jin Lu
role: PRINCIPAL_INVESTIGATOR
References: