Trials / Recruiting
RecruitingNCT06049290
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 342 (estimated)
- Sponsor
- Nanjing Leads Biolabs Co.,Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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 includes two parts: phase I and phase IIa study. The dose escalation and dose expansion studies for LBL-034 will be conducted in the phase I study to evaluate safety, tolerability and determine RP2D. The efficacy of LBL-034 in the treatment of R/R MM and R/R leukaemia plasmacytic (plasma cell leukemia, PCL) will be evaluated in Phase IIa study.Phase IIa clinical study will be conducted after obtaining the RP2D.Determine the specific dosing regimen in Phase IIa based on the safety, PK and other data from Phase I clinical studies.Phase IIa clinical study includes 4 cohorts.This trial requires collection of biological samples from all subjects for relevant testing. This clinical trial will enroll 342 patients in Phase I and Phase IIa studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LBL-034 for Injection | Initial dose - MTD; Q2W; intravenous infusion |
Timeline
- Start date
- 2023-10-20
- Primary completion
- 2026-10-20
- Completion
- 2027-05-20
- First posted
- 2023-09-22
- Last updated
- 2025-12-04
Locations
26 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06049290. Inclusion in this directory is not an endorsement.