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

LBL-034-CN001

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.

2023-10-20

2026-10-20

2027-05-20

Recruiting

Early phase I

418

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 418, 'type': 'ESTIMATED'}}

2024-04-17