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

Launched by NANJING LEADS BIOLABS CO.,LTD · Sep 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LBL-034 for patients with relapsed or refractory multiple myeloma, which means their cancer has come back or hasn’t responded to other treatments. The trial aims to understand how safe the treatment is, how well it works, and how it behaves in the body. It is currently open for enrollment, and anyone interested can join if they meet certain criteria.

To be eligible, participants must be at least 18 years old and have been diagnosed with multiple myeloma. They should also have a life expectancy of at least 12 weeks and be in good enough health to participate. This means they should have a performance status that allows them to carry out daily activities without too much difficulty. Participants will receive LBL-034 and will be closely monitored for side effects and overall response to the treatment. It’s important for potential participants to discuss any recent surgeries, other medications, or health issues with their doctor, as some factors might prevent them from joining the trial.

Gender

ALL

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.