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

Overview

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.

Interventions

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

Primary outcome measures

• 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).]
• Dose-limiting toxicities（DLT） [Time frame: 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).]
• Maximum tolerated dose (MTD) [Time frame: 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 outcome measures (6)

• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• sBCMA [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)]

Eligibility criteria

Inclusion criteria

• 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；
• 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 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；
• Subjects with an active infection that currently requires intravenous anti infective therapy;
• The patient has a Medical history of immunodeficiency, including HIV antibody positive;
• Women during pregnancy or lactation;
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 26 centers

• The First Affiliated Hospital of Wannan Medical College — Wuhu
• Peking University People's Hospital — Beijing
• Peking University Shougang Hospital — Beijing
• Fujian Medical University Union Hospital — Fuzhou
• The First Affiliated Hospital of Xiamen University — Xiamen
• Sun Yat-sen University Cancer Center — Guangzhou
• Shenzhen Second People's Hospital — Shenzhen
• The Afliliated Hospital of Guizhou Medical Univeristy — Guiyang
• … and 18 more centers

Identifiers

NCT: NCT06049290 · LBL-034-CN001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗