Testing LBL-034 for patients with relapsed refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of LBL-034 in patients with relapsed/refractory multiple myeloma. It consists of two parts: a phase I dose-escalation study to determine the recommended phase II dose (RP2D) and a phase IIa study to assess the efficacy of LBL-034 in treating the condition. The trial aims to enroll 342 patients and will include various cohorts in the phase IIa study based on data from the phase I study.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Wannan Medical College
  Wuhu, Anhui, China Recruiting
• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Shenzhen Second People's Hospital
  Shenzhen, Guangdong, China Recruiting
• The Afliliated Hospital of Guizhou Medical Univeristy
  Guiyang, Guizhou, China Recruiting

Study contacts

• Principal investigator: Jin Lu — Peking University People's Hospital
• Study coordinator: jin lu
• Email: mengdongtao@leadsbiolabs.com
• Phone: 025-83378099

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.