Status:
RECRUITING
A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma
Lead Sponsor:
Nanjing Leads Biolabs Co.,Ltd
Conditions:
Relapsed/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2027
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT06049290
Start Date
October 20 2023
End Date
May 20 2027
Last Update
December 4 2025
Active Locations (26)
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1
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China, 241001
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
3
Peking University Shougang Hospital
Beijing, Beijing Municipality, China, 100144
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000