RecruitingPhase 1Phase 2NCT06049290
A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma
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
Sponsor
Nanjing Leads Biolabs Co.,Ltd
Enrollment
342 participants
Start Date
Oct 20, 2023
Study Type
INTERVENTIONAL
Conditions
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-034 in patients with Relapsed/Refractory Multiple Myeloma (R/R MM).
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria8
- 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.
Interventions
DRUGLBL-034 for Injection
Initial dose - MTD; Q2W; intravenous infusion
Locations(26)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06049290
Related Trials
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
NCT0497360583 locations
A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)
NCT07391657108 locations
A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
NCT0516058486 locations
Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
NCT0586201211 locations
ELISA in Relapsed/Refractory MM
NCT068328653 locations