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A Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllNanjing Leads Biolabs Co.,Ltd
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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,or according to the IMWG 2021 diagnostic criteria, the proportion of circulating plasma cells in peripheral blood is ≥ 5%,have documentation to diagnose PCL; 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 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.
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What it tests

  • LBL-034 for Injection
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Where

21 sites
The First Affiliated Hospital of Wannan Medical College
Wuhu, China
Peking University People's Hospital
Beijing, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Shenzhen Second People's Hospital
Shenzhen, China
The Afliliated Hospital of Guizhou Medical Univeristy
Guiyang, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, China
The First Affiliated Hospital of Henan University
Luoyang, China

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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