This trial is a single-arm, open-label, multicenter phase I/II clinical study of LBL-034 in patients with RRMM to evaluate the safety, tolerability, PK profile, immunogenicity and efficacy of LBL-034.
Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form;
Age ≥ 18 years at the time of signing the informed consent;
Eastern Cooperative Oncology Group (ECOG) Performance Status Scale≤ 1；
Documentation of initial diagnosis of multiple myeloma according to IMWG diagnostic criteria,or according to the IMWG 2021 diagnostic criteria, the proportion of circulating plasma cells in peripheral blood is ≥ 5%,have documentation to diagnose PCL；
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 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);
Patients with active hepatitis B or C；
Single group
LBL-034 for Injection
DrugQ2W; intravenous infusion
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(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 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.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 .
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 in Phase I.
Occurrence of adverse event (AE) and serious adverse event (SAE)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-034 will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase I study.
Cmax
Maximum drug concentration in plasma after administration.
Tmax
After administration,Time to reach maximum drug concentration in plasma.
Immunogenicity
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.
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.
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